Good morning, ladies and gentlemen. My name is Jan H. Egberts. I'm the Chairman of the Board of Directors of Nordic Nanovector. Welcome to our second quarterly release and first half of 2022 results. Together with me here are Malene Brøndberg, our CFO and Interim CEO, and Lars Nieba, our Chief Technology Officer. On the first slide, I need to share with you our safe harbor statement, basically about forward-looking statements. I really urge you to pay attention to this. First of all, a quick update. Unfortunately, as you all have heard, we had to discontinue the PARADIGME clinical study studying Betalutin. The reason, as has been shared before, is the difficulties in enrolling sufficient patients into that study, which made the board consider where we are and do an interim analysis.
That interim analysis was executed by an independent review board, which basically came to the conclusion and the board came to the conclusion that the regulatory feasibility of getting this product approved was such that it made no sense to continue the clinical study. Obviously, a very unfortunate and unexpected outcome. Based on the efficacy data which I spoke about, and also the fact that given some of the recent developments in the marketplace, in particular as relate to bispecific monoclonal antibodies, we did not feel that this was a result that would yield a regulatory approval. Based on that feedback which has been communicated to the market, the board decided to restructuring and to that support.
To initiate that, we have requested support from Carnegie and we're working together very closely now to explore various strategic options for the company moving forward. I'm sure some of you will have some questions, so at the end of the meeting, we'll allow you to ask some questions to go a little bit more detail about these top-line, this top-line slide. Just to go a little bit more detail about the PARADIGME situation and the discontinuation of the study. Obviously we have communicated a number of times the recruitment. Initially the recruitment was not particularly good. Lars came on board, recruitment significantly increased, and then unfortunately Corona hit, which really created a drop-off in the recruitment.
Particularly over the last couple of months of May and June, the recruitment was very slow, and we started to kind of weigh on one side the amount of cash we had available, and on the other hand, the recruitment rate. If you look at the two, we as a board felt that we need to take a step back and analyze where are we. The COVID impact is across many, many clinical studies, particularly in the oncology field. The primary reason for that is that patients with cancer, oncology patients, often are very reluctant and the doctors are very reluctant to take them to the hospital because the hospital is being seen as a very dangerous place for those people, that they could get infected by Corona.
Many of those patients stayed home and obviously didn't go into the clinical study. The other area I already touched on before is the fact that the bispecific antibody really emerged very rapidly on the clinical arena. Like I said before, we initiated an independent review on the efficacy data of the PARADIGME. That review concluded the efficacy data will not yield Betalutin a competitive profile in third-line follicular lymphoma, particularly not a profile that would allow us expedited approval. That's a very important thing. A couple of comments about the independent review. The independent review was done by an outside physician and a statistician. What a lot of people think is that we actually have all the data available, basically that we can fire up our computer and look at it.
That's not the way it goes. The direction from the FDA are very clear. These data go into a confidential file where only selected individuals, in particular external individuals, can look at the results. The primary reason is that people don't want you to look every week how you're doing in your clinical study. The reason for that is you need to maintain the integrity of the clinical study. To that extent, number one, we as a board or management did not have access to the individual patient or the patient's results and the patient data, only an external review. Secondly, FDA is very reluctant to have multiple interim reviews. As you know, we had one in 2020, and it was a very special decision by the board to do an additional one.
Currently, we're winding down the study as predictably as possible. Basically, the company has some responsibilities in terms of following up the existing patients, so there are some ongoing costs associated with that, and Malene is going to talk about it in more detail later on. Some limited analysis will be done to meet the reporting requirements. Eventually there will be a report out there kind of summarizing the top-line results of the clinical study. However, what I think is very important to know is obviously the phase I clinical study, the limited study, was very positive. We're still trying to understand what happened there. There are clearly still utility of this compound in other and additional clinical studies.
That's one of the things we're looking at it. Obviously it might be the mouse variation, the Betalutin, or it might be the more humanized variation, which is the Humalutin. The clear efficacy or potential of the compound, we still believe in, although it didn't work out in this clinical study. Having said that, I'd now like to hand over to Malene, our CFO and interim CEO.
Thank you very much, and also good morning from me. Yeah, as Jan said, it is a very serious and also a very unfortunate situation we are in here, which unfortunately, of course, meant that we have to start to make people redundant. The status right now is that 25 staff members have been made redundant, which is approximately 70% of our staff. We have also slimmed down the leadership team, and that's significantly. That was slimmed down by approximately 60%. We have started, and this process of course started already the day after we announced this, that we closed the PARADIGME. We are now going through at least 300 plus contracts.
Some of the bigger contracts, llike with our CROs and a CRO, I know there's been a lot of speculation. You can actually look it up on ClinicalTrials.gov. It's been there all along. It's ICON. We are, of course, having negotiations now with them because we need to wind it down in a compliant way, and follow up on the patients that we have in the trial. Those discussions are ongoing. The discussions are ongoing with, of course, also our big suppliers on the CMC side. Here you could just see the Q2, which came in on a spending or the costs were NOK 103 compared to NOK 104 last year. Basically in line.
You could see here what the cash outgoing in Q2 2022 was lower than the Q2 2021. That is, of course, good. We have in there also or we have to pay what is called a change order for the CRO. That is not in that number, which of course also need to be deducted. We are right now, and as you can imagine, the team is working 24/7 to close the contracts as soon as possible. We expect the close of the contract to be or the cost to be in the level of NOK 170 million–NOK 200 million. You say that is an awful lot of money. Yes, it is.
Unfortunately, we are in a industry that is a very, and of course, that is good for the patients, which is why we're here, a very regulated industry, which means that there is a lot of regulations that we have to comply with. This indicates a cash position of roughly NOK 90-NOK 110. As Jan also just said, we have engaged Carnegie to help us with the focusing on realizing the shareholder value. As you know, I'm a shareholder myself, so of course, we will do everything we can to get the best out of this situation. We have some key assets.
We still have a good pipeline with the CD37 headed up by our guy Jostein Dahle and his brilliant team. We also have, as Jan just said, Betalutin/Humalutin. We have an Oslo listing, and then we have some cash. What we have in terms of staff, we have the R&D team. We have a very few people now on the admin, and then we have a very limited team left as well on the leadership team. That team is now, of course, trying to push forward in the best possible way. The strategic review is expected to run into Q4 2022. Thank you.
With that, Jan, I will hand it back to you.
Thank you. This is the final slide, and then we want to see if there are any questions. Like I said before, the decision to discontinue PARADIGME, yeah, that really followed the independent external review. Very unfortunate outcome, but I think it was very important to make this decision so we can reposition the company in time. This really prompted a restructuring of the company. Malene and her team and Lars have already taken significant steps to reduce staff and terminate the various agreements. Over 300 agreements, as Malene mentioned, so that's not a trivial task. Particularly as an organization that has been significantly slimmed down, a lot of work is being put on the shoulders of a relatively small number of people.
Currently, we're reviewing various strategic options with Carnegie and to realize shareholder value, and we'll communicate back as results come out of that. Having said that, I want to open the floor for some questions.
Here we also invite Lars, our CTO. We start with the audience. Yes.
My name is Ivar Aasrud. Speak English or Norwegian?
If you can English. Otherwise, we need to do-
Yeah, yeah
Simultaneous translation.
My name is Ivar Aasrud. I'm a shareholder. I think you need to explain a bit more about the Carnegie mandate and the timing. Malene said into Q4. Do you have a firm date, or is this just some endless ongoing work?
The mandate is to look for strategic options for the company in the broadest sense. That could be looking at other companies where we could potentially merge into and other things that are available. In terms of timing, as expeditiously as possible. I cannot predict the future. We're working very hard at it, but I cannot give you a firm timeline.
This is just words, Jan.
Sorry?
This is just words. You have to be more firm about this.
No, I cannot be more firm.
Could you in baby language explain to me what can Carnegie provide which the board and management can’t provide?
Well, Carnegie has a lot of access to companies that we have, but it's. They are very experienced in that. Obviously, like you know, the team has been slimmed down significantly, and Carnegie is helping us with this process. Very customary, number one. Number two, in case we do have a transaction that makes sense from a strategic point of view, we need advice if the valuation is correct, both our valuation and the valuation of another company.
In the press release on the 21 June, you said that you should give some feedback regarding FDA. What's that?
There were communications back and forth with the FDA, and basically based on those evaluations. You want to provide the more specifics?
Yeah, sure. Thank you. Yes. Based on the results we got on the 21 June, we were in contact with the FDA. We got several written feedback from them. Based on that feedback, we went together with the board to conclude what the FDA has written, which is confidential. The board concluded that a pathway forward for accelerated approval is not a path forward. We could go forward.
It's not viable. Yeah.
It's not viable. We could go forward, we would have to do then a phase III trial in third-line follicular lymphoma, which the board said is not a competitive or a viable option from a financial point of view.
Andreas Spi. Just a quick question on tax loss carryforwards. It's not on your list, so I was wondering if there's a value in the cost that you've accumulated over the years.
Yes, of course. There is a carry forward and i t is of course also on our list. That said, it has to be a very specific situation. We've of course also looked at that from a legal point of view, how does that work? It's not straightforward. Of course it is there as well. Absolutely.
It needs to be the same industry, and there needs to be a lot of overlap. The reason we didn't mention it is we're not tax accountants, but we have retained advice from tax consultants. There are very specific requirements in order to use it. It's clearly one of the key assets we're looking at.
First of all, congrats to Malene on the new position. Do you consider the combination treatment with Betalutin and rituximab to be a valuable asset for the company?
Yep.
Very good question. Yes, sure. As you know, our Archer-1 trial was a trial which showed pretty good results and part of the interaction which we had with the health authorities in particular, of course the FDA, was to think about how can we move forward in a combination therapy in second-line follicular lymphoma and one of the possible combination partners is of course rituximab. We have a synopsis for that, but to move ahead and as pointed out by Jan, we do see the potential to move ahead with either Betalutin or Humalutin and if so, we would do it in a combination trial.
Just to be clear, that would require a new study.
A partner. Yeah.
Yeah. It would require a new study.
It would be a phase II, phase III.
very significant expenses. It's not...
Well, thank you for the answer. Some quarters ago, you were asked why you didn't recruit more patients into the Archer-1 study. Marco Renoldi answered, because you had got the answer you needed already. Could you be a bit more specific about what types of answers you got from those seven patients which, as far as I can see now, have obtained a median duration of response of three years?
Yeah. Before you answer that, I want to make some comments. In the pharmaceutical industry, when we look at a new drug or treatment, we have different phases and the objective of each phase is different. A phase I study is a very early exploratory small study for a relatively modest cost. Typically 10-15, anywhere depending on the indication from 8 to 20 patients. Really you're trying to test what kind of results that you need. In the phase II, which this study essentially was a phase IIa or IIb, you're really starting to look for efficacy. Does the compound work? Some safety data.
The phase III, which sometimes you have to do particularly in chronic treatments, you look for safety data. The results vary very significantly. Typically about 60% of the compounds don't make it past phase I. Between phase I and phase II, there's another drop of depending on the therapeutic indication of about half to 60% of the compound. The fact that Betalutin didn't work out is very unfortunate, but it's still very much in line with what the industry is. It's about 50%. The phase III studies, which you tend to do in more chronic diseases, there the drop-off is often less.
If there's a drop-off, it tends to be more because of safety issues than of efficacy issues. Safety issues are typically less relevant in oncology because these patients are already really sick. That's kind of to put in perspective what the role of the different phases in the clinical results are or in the clinical studies are. Now I'd like to give over to Lars to answer your question.
Okay, thank you for the lecture.
It kind of was what Jan pointed out. We had eight patients in the Archer-1 study, and we show some good indications for efficacy. That is why we went forward with that eight patient number to the health authorities to discuss with them what is the best way forward. As mentioned, we have a synopsis, and that synopsis was discussed with the FDA to say how fast can we move ahead into a phase II/III study. That is why we said, yes, we do have enough data to move ahead into the next phase, as pointed out by Jan.
Yeah. The thing you need to keep in mind, each phase obviously, as a board, you have to weigh the expenses against the potential results. If you make a very large phase I study and knowing that a lot of compounds fail, in essence you're quote-unquote wasting a lot of studies. You always need a phase II or a phase III for approval. It doesn't make sense to make it too large phase I clinical study.
Well, could you still be more specific about what type of answers you got from those seven patients? I just referred to Renoldi.
As mentioned, we have seen good efficacy. I honestly don't have it now directly at hand. To my knowledge, we have still five patients in response. Oh, sorry. It was seven patients, not eight. Out of the seven patients, the median duration of response. Honestly, I haven't done my analysis yet. The complete response rate was pretty good, so that is why we moved ahead, and that was the most important part for us.
Okay, thank you for the answer. The last quarter you said that you had shared clinical data with a potential partner. Are you still in dialogue with that potential partner?
What are we referring to? I'm not aware. I'm not aware of that statement, to be honest, so I cannot comment on that, and I'm not sure who made that statement.
Well, it's in your report.
I'm not aware of that.
I think.
Maybe Skullerud said it on the presentation, but I'm sure he did. I'm sure either it was in the report or Skullerud said it on the last presentation.
I'm not aware of that statement, so I cannot comment on that. I was in that presentation, but I don't recall it.
I think what Erik might have alluded to is that there is a constant, of course, outreach both from the company and also coming in, of course. That's just nature of the business.
Yeah, that you had said many times, but the last quarter he said that, you also had shared data with a potential partner.
I can't recall that. Yeah, there are discussions all the time, of course. It's all. If that's
I suppose that you are not sharing data with everybody all the time.
No, I don't think.
I guess that's in a non-disclosure environment.
We can't collect data. No. We can't.
No, we don't.
We're not.
No.
No, we're not. There's of course discussions with companies, but no, we're not sharing the data.
I mean, also to remember, very important, we don't have any additional clinical data until two months ago beyond the interim analysis from 2020. Again, I start to repeat myself, my apologies, but it's not like on a day-to-day basis we know how the clinical study is going. There are very distinct moments. When you start the study, you don't know anything. You're completely black in the fog until you do an interim analysis when an outside review board looks at the data. Then you don't know anything for the whole period until the board decided to do the second analysis. It's not like every day you open your laptop, like, you look at your revenue as an example as a company. That's not the way it works. It's all confidential in a confidential database.
Nobody from management or the board has access to that. That is a requirement of the FDA, the Food and Drug Administration.
Okay. Since you mentioned it, I find it a bit hard to believe because I see some inconsistency between your statement right now and Lars Nieba, some quarters ago because I gave him the question if somebody in the company had access to the clinical data in the PARADIGME study. Lars Nieba said just a few people had access to that study.
Yeah. Let's clarify that because I don't want a misconception to exist.
Yeah, as Jan pointed out and also how the interim analysis went forward, yes, there was an independent review board where we had a Statistical Analysis Plan, so-called SAP. That one was then evaluated by the independent review board, and the results from that board, we as a leadership team and the board, only a few people, not the whole leadership team, very few selected people got access to make a decision.
To the results.
To the results.
Not the raw data.
Not the raw data.
Very clear. Not the raw data. You have to remember, there are literally 10,000 individual scans of all the patients being made. And those get reviewed by an outside physician. He basically says, "Is there still cancer or is the cancer gone away?" In remission. We don't have access to that data. That's an outside independent physician. Basically they do the analysis. Before you start a clinical study, you have a so-called SAP, Statistical Analysis Plan. Before you start it, you need to agree that with the FDA, and that's what you execute. An external statistician executes it and then writes a report which summarizes the data. It doesn't say Mrs. A has cancer and Mrs. B does not have cancer, et cetera.
It says X% of patients have this, Y% of patients have that.
Okay. Thank you for your answer.
I have to come back to the Carnegie study. It seems to me to be very open-ended. There must be some deadline. What are you actually? I asked the mandate, and you said gave me three or four points. There must be some more written statement in this agreement. We can't accept some open-ended study from the board. That is.
It's not an open-ended study. It is helping us.
Well, give me a date.
I'm not giving you a date.
What is the agreement with Carnegie then?
Carnegie is helping us evaluate strategic options for the company.
That's words. Give me some more statement.
That's all I can give you.
This is not acceptable, Jan. This is ridiculous.
Okay. Are there any questions in the audience? Or otherwise we go to the online. How do we conduct those questions? Are you reading them?
Jan, I can read questions from the online submissions, if you can hear me okay.
Yeah. I can hear you fine, thanks.
Okay, thank you. We'll start with a few questions on PARADIGME. The first question is that asks the difference in signs of efficacy between Lymrit and PARADIGME seems to be quite significant. Finding subsets in PARADIGME with differing efficacy seems like the imperative task to crystallize shareholder value. Can you shed any light on your logic to either pursue or not the further analysis of subsets in terms of data response?
Sorry, I couldn't hear it very well. Would you mind repeating the question?
Yeah. The question essentially is finding subsets in the PARADIGME data sets with differing efficacy.
Yeah. I got it.
Seems like an important task to crystallize value. Can you shed any light on that?
Yeah, I can shed light. We have looked obviously at that, if there are subgroups. The issue is if you make subgroups, they become very small. The total sample is already not very large. If you start creating subgroups, those are even smaller and you really start to lose statistical power. The opportunity to have statistical significance significantly reduces.
Yeah. Absolutely, Jan. Is it on?
It's on, yes.
Okay. Thanks. The other part of the first question is, if I got it right, is: what is the difference between part A and part B? Because, we have seen difference in efficacy in between part A and part B. Yes, it's true, and we looked into that one, and we do have a significantly different patient population. After the part A, we also discussed of course with the health authorities, our new protocol, and our patient population in the part B was a patient population which was far more heavily treated.
To quote one of our investigators, they said, "Look, your patients in part A were at the cliff, whereas in part B, they're falling off the cliff." We tried to get some back, and at least in one-third of the patient population, we got some back. That was not enough for us. Whereas in part A, we show 70% overall or objective response rate, but they were still far healthier. We still believe in our one-time injection. That is why we also discussed potential ways forward.
Yeah. The key hypothesis we have that because of corona, a lot of patients who really could have benefited from Betalutin stayed at home. Physicians tried to keep them at home as long as possible, and then only at the last moment they took them to the hospital and included in the clinical study. To Lars's point, we got patients with a significantly worse prognosis in the latter part of this in the PARADIGME clinical study. That's just an unfortunate outcome of the corona situation.
Thank you. The next question just asks for some further detail in terms of the fact that you've said that approximately a third of patients responded in the trial. Can you say anything further about the split between complete responses and partial responses in the context of the overall response rate?
Honestly, I don't have it at hand, but we will answer that question then online.
Yeah. Obviously we will publish the results probably in the first half of next year. The results need to get analyzed and synthesized, and will get published in the first half of next year. That's a requirement of the FDA, so just want you to be aware of that.
Thank you. A further question which I think, Lars, you've probably pretty much answered, but this question asks, do you have any further theories on why the interim results deviated so much from what has been presented earlier in the trial?
Yeah. There are two things you need to keep in mind. First of all, phase II clinical studies always will yield lower results than phase I. The reason for that is a phase I study is a very small, very controlled study in a relatively small patient population. You always expect a little drop-off in the phase II and we did see that, but particularly in the interim analysis, but nothing to be concerned about.
Secondly, because of the corona, like I mentioned earlier, the hypothesis, and that's not scientifically proven, but the hypothesis is that patients stayed home longer, the physicians kept them at home as long as possible, and only at the last moment when the patient and the physician were essentially with their back against the wall, they decided to include them in the clinical study.
Thank you. There are a couple of questions regarding a potential path forward for Betalutin, which again you've alluded to in comments, but essentially asking, given the failure of PARADIGME, how confident are you with regards to a potential path forward for Betalutin?
Yeah. As mentioned, we are still believing in Betalutin/Humalutin as a one-time treatment. I think what we have shown in all of our studies in PARADIGME Part A, PARADIGME Part B, DLBCL and Archer-1 is that Betalutin really works. We have shown that. Now, the point is what we have seen is that a lot of new compounds were coming up, and the objective response rates you have to reach in today's world are pretty high. You're more reaching 60%, 70% or more. What we are looking forward now is what is the right combination partner which we can use in combination with Betalutin to move ahead. As said, we do have a synopsis.
However, I think we need to find a partner because our financial muscles are not where we would like to have them, of course, for such a study, and going into another phase II, phase III is quite costly. Yes, that is one part of our asset. As Malene pointed out, it's still a very important asset of the company.
In particular, with respect to these new compounds that Lars Nieba was alluding to, initially we had an approach with an expedited approval, which wouldn't require us to do a phase III clinical study prior to approval or prior to market launch. Now the threshold has risen because some of these novel compounds, in particular these bispecific monoclonal antibodies. You would look at a new clinical study very similar to what we have done here, number one. Number two, the pathway which we had in the past, which was an expedited approval is not viable anymore. We probably would have to do a phase III clinical study prior to approval.
Which is not necessarily a problem in a very large indication, but a smaller indication like third- line where we were initially, which is by definition a smaller indication.
Yeah
that is less viable.
Thank you. We have a number of questions regarding the costs of closing the PARADIGME trial. Firstly asking, can you give any further breakdown of where those costs are going? In particular, what proportion of those costs are planned to go to ICON?
Yes. As I said, we're showing a combined number today, and as I also said, we are in the middle of the negotiations. To stand here to say what we expect would probably not be right. I'm sure everyone can appreciate that. If you're extending your house and then you're trying to negotiate price, you probably won't tell the builder what you expect in terms of the price. You of course have something in your mind, and we're going to do everything we can to get the best deal. As I also said, this is a heavily regulated industry, so there are standards and compliance that we need to follow. Of course, we have a follow-up plan.
When you close, if we take a step back, when we took the decision to discontinue PARADIGME, you have a 14 or 15 days window to basically come up with the plan for how you want to follow up with the patients. Then that goes back into your CRO, which here is ICON. Then that sort of is an information to all the countries, and then they sort of have to look and agree, or come up with if they have any objections to it at least. After we had that's why it takes a while to get to these negotiations, because not until we have that, we know what we need to ask from ICON and what they need us to help with.
Our biggest cost in general is CMC and of course the clinical. I'm not going to, for that reason, say today what is what. As I said, I'm a shareholder myself. I've taken this on because I will try to make the best deal for everyone.
Just to put a little bit more meat on the bones, as the Americans say, when you discontinue a clinical study, you still have to follow up the patient. That's an ethical medical requirement. You cannot just say, "Sorry, sorry, patient, the study didn't work. You're on your own." That is not the way it works. You have to continue to follow up the patient, so there are costs associated with it. As a matter of fact, Lars was alluding that still some of the Lymrit patients we're still following up. Yeah. That has some cost, and those costs are unpredictable because they're typically elderly patients. You don't know how long they're going to live. I mean, let's take the disease out in general. I mean, they are at an elder age.
There is a medical- ethical requirement that you follow up the patients, and the company needs to incur the cost. That is what you have agreed when you start a clinical study.
Thank you, Jan. Just one follow-up question in that regard, which is for how long do you think you may have to carry the costs for winding down PARADIGME?
Essentially unpredictable.
As I said, we have more than 300 contracts we've been through. Some of them, the smaller ones are of course easy to get out of, but of course the bigger ones, that's where we have to be on our toes to get the best deals. For us of course, we know the suppliers of course want the best deal for them, so it's going to be down to the negotiation of course. Sorry, we can't go into it at this stage. We will of course at a later stage be able to say exactly where we are, but today we can't say more unfortunately. We worked day and night to try to get this going as fast as possible.
We worked throughout the whole July to get this to go together. Of course, unfortunately also had to make people redundant.
Yeah. Trust me, I've been associated with a lot of different companies. I have not seen many people work as hard as Malene is currently doing, trying to minimize costs. I want everybody to be assured that it's all hands on deck. People are working super hard. Nights, weekends, et cetera.
Thank you. The next question is also about costs, and asks.
I'd like to say something.
Can you say anything more about which employees are still left in the company, including in the senior management team, and whether or not there will be any further cost reductions, and potentially reductions in pay?
To comment on that, I don't think we can go specific who is, who is left, who is gone. Obviously we have a new CEO. From a philosophical point of view, I'm not a believer if you ask to work our people super hard to ask them to take a pay cut. It's an unfortunate outcome of the industry we're in, so I'm more a believer, like you take certain, positions out, and don't ask everybody to take a pay cut. These people work super hard. It's not their fault that the compound didn't work out. It's just an unfortunate outcome of the industry we're in.
I think I said when I presented that, who's left, we of course have Jostein Dahle and his team, which is an excellent team. Then we've got a few left on the management side to make sure that, of course we still need to report, we are still on Oslo Børs. There is still a lot of work. It's very expensive actually to be on Oslo Børs. So all of that still needs to happen, despite that we are closing down PARADIGME. Of course we have. I think we could say now we have cut into the bone.
Of course, I'm here in an interim capacity as well, so of course we can rule it out. Of course it depends on what happens next, which is where Carnegie comes in and are helping us. It is, just to come back to the Carnegie question again, it is also a very extensive, a big process when it comes to documents that need to be put into place. It's not just straightforward. It's not just lining up targets and then trying to agree, and that's why it's also difficult to put exact timing on it because it's a little bit like, sorry for the analogy. It's a little bit like dating. You have to make it happen and that's why.
We want of course to try to get the best deal, and that's why we trimmed it down as much as we can in terms of the cost, so that is aligned with what we need to do. I understand it's difficult just to get the. We can't say it's this day when we. We are working as fast as we can.
Give me a figure. What's the budget?
For?
For Carnegie.
It's a deal between us and Carnegie. We can't go into that. We won't go into that on any of our suppliers. That's the same here.
Success- related, I can tell you that. Any more questions?
Thank you.
from the webcast?
A couple more questions, Jan. Just one further question on costs, which asks, given the costs associated with closing PARADIGME, can you give any estimate for how long the cash runway will be with the NOK 90 million–NOK 110 million that you estimate you'll have?
We can't right now because again, first we need to close those big important contracts or get those negotiated and get them in. That's step one. Step two, of course, is that we need to in general also figure out what we do with the pipeline. As I said, we have Jostein's team working really hard, doing a great job. Of course, we have a lot of in general as Lars also said, Betalutin, Humalutin. We've got a lot of assets and what we do there going forward is still under review.
Thank you.
Go ahead.
Just a couple of questions on the pipeline. The first asking, are you still working as usual with Alpha37, and are you still in partnership with Orano Med on that compound?
Yes, we are. We are still working on Alpha37, and we are, of course, still working with Orano Med. That's our partner, and we are making progress there as well.
As I said, our CSO, Jostein Dahle, is still in place and working full speed ahead and doing a great job.
Thank you. Just lastly on the pipeline, a question asking, in case you're considering combining Humalutin with Rituxan in combination, can you remind us how much clinical data you have on Humalutin at this point in time?
Sure. It's pretty easy. We only have preclinical data. We would need to go, of course, first in a phase I study with Humalutin, but it would be a very short phase I study to identify the right dose.
Very similar to what we did with Betalutin, phase I and then 2A, 2B, and then most likely also a phase III clinical study prior to approval.
Thank you. One last question, which simply asks, what value do you see in an Oslo Stock Exchange listing?
No, I mean, there is significant value. I mean, there are a lot of companies that are trying to go public and there's a lot of paperwork associated with going public and S-1, as they call it in America, and a couple of other documents. So it's very significant. Exact monetary value I cannot put on it, but it is very significant.
It takes roughly six months to go public. Of course, as you can well understand it, this in this market it's difficult. That's of course a
Success is not guaranteed.
No.
Okay.
Thank you. That's all the questions that we have posted online at the moment.
Okay. Thank you very much, everybody. Again, sorry that we had to share this situation, but it is what it is, and we're working on the plan moving forward. We're working on that.
Yeah.