Good morning, ladies and gentlemen. My name is Jan Ekberg. I'm the Chairman of the Board of Nordic Nanovector. Together with me here are Peter Braun, our new CEO as well as Malene Brandberg, our CFO and Marco Rinaldi, our Chief Operating Officer. First of all, I'd like to emphasize the forward looking statement.
We're obviously a public traded company. So please read this carefully when you're considering investing in our company. Today, I'm going to cover a couple of the highlights prior to Peter joining us and then I will introduce Peter and then I will hand over to him. So kind of before shortly before Peter joined us, we had a very successful private placement in February, but in addition an oversubscribed repair offering in April, which is a very good indication, which raised about NOK 422,000,000 or about US48 million dollars in proceeds. It really helps our runway all the way through into the second half of twenty twenty two next year.
As you're aware, We made some very significant protocol changes to the PARADIGM study, which really helped us improve our execution and the recruitment last year. In addition, we released earlier this week some very promising Phase Ib data from the ARCHURE 1 study where we evaluated Beneluton together with rituximab in second line follicular. In addition, we had some change on the Board, as you're aware. Hilda, after a number of years, unfortunately, was not able to stand for reelection at the AGM. So she has left our Board.
And Solve Haldebast was appointed as a new Non Executive Director at our most recent AGM on April 28 this year. So some changes on the Board. And then finally, obviously, you have read the announcement and some of you have seen Peter in Some presentation, but I now like to introduce Peter to you and hand over the presentation from here onwards to Peter. As you know, Peter has over 30 years of experience with Swiss Roche, including launching a number of very important products like Herceptin and Terceva. In addition to some of these marketing roles, he also had some general management roles and some other commercial roles and being involved in launch activities.
So very relevant experience for our company as an oncology company and we're very pleased that Peter has decided to join us. So with it having said that, finally I'd like to thank Lars Niwa for his energy over the last year, where we really made a major change and a major improvement to the company. And now I'd like to hand over to Peter, who'll take you through the rest of the presentation. Thank you.
Great. Thank you, Jan, for the kind introduction. I'm excited to be here on my first quarterly call with Nordic Nanovector, and I'm even more excited to be leading this organization to the next stage in our journey. Prior to going into the quarterly update, I'd like to take just a couple of minutes to briefly introduce myself and highlight Some of the elements that I think are relevant to Nordic Nanovector. As you can see, a large part of my career has been at Roche, where I rose within the leadership ranks and had the opportunity actually to learn from the best on various dimensions In oncology ranging from commercial to development and into access.
I had the opportunity to lead a variety of Country organizations both in developed as well as developing countries as well as at the global level. I also directly led and indirectly drove multiple launches of brands such as Herceptin, MabThera, Avastin and numerous other oncology and non oncology products. Many of these are actually monoclonal antibodies, which are now [SPEAKER DOCTOR. PAUL EDGECLIFFE JOHNSON:] PAUL EDGECLIFFE JOHNSON:] Indeed, standards of care in the clinic. Possibly the most relevant part of my career that is relevant To Nordic Nanovector was when I was leading the Herceptin project during what was possibly the most exciting period of its lifecycle and certainly a product that I think everyone can agree changed medical textbooks and changed the lives of countless patients suffering from not only breast cancer, but also gastric cancer.
I had the privilege of leading a cross functional team, which stretched from commercial to medical to clinical science, clinical operations, manufacturing, regulatory and even into diagnostics. Additionally, as lifecycle leader of Herceptin, which was Was and still is the lead compound of the HER2 franchise. I was also deeply involved in the early clinical development of the HER2 sisters, those being Perjeta and Kadzyla. And of course, Kadzyla is the armed version of Herceptin. So I'm also familiar with armed monoclonal antibodies.
Since having left Roche, I then dove straight into the exciting world of biotech, which is of course more resource constrained. And now since the 6th April, less than 2 months, I have the privilege of leading Nordic Nanovector. So I'll change gears now and I'll share with you why I joined Nordic Nanovector. And I think this also serves as a nice summary of why I believe investors, other stakeholders and then ultimately patients [SPEAKER DOCTOR. BILL SHERIDAN:] Bill Sheridan:] First of all, at a high level, radiopharmaceuticals clearly have a key role to play In the treatment of cancer, it serves as an additional modality in attacking this disease.
Radiopharmaceuticals have previously Been underappreciated. The interest, however, has increased noticeably over the last couple of years. This increase It's largely the result of the evolution that we've seen in the technology and the platform, which actually allows now for better targeting, Better efficacy and better safety profiles. So within this context, Nordic Nanovector and more specifically, Beta lutin is playing a key role. Within the radio immunotherapy space, beta lutin is one of the most attractive and advanced in clinical development with compelling data in treating non Hodgkin's lymphoma patients.
The first step Of this journey is in, as you know, 3rd line follicular lymphoma patients, particularly in the 70% of those patients who are elderly and frail and resistant or refractory to anti CD20 immunotherapy. We've made significant progress in executing PARADIGM. Will be sharing more information on that shortly. This of course is the pivotal Phase 2b trial. Lastly, Beta Luton is but the first step of the portfolio and we continue to explore how to best leverage the assets that we have in the company as well as the deep heritage that we have in this space.
So, [SPEAKER DOCTOR. BILL SHERIDAN:] Bill Sheridan:] Our mission is to develop innovative targeted therapies for hematological cancers where there is a high unmet medical need. As you know, non Hodgkin's lymphoma is a common cancer and approximately 150,000 new cases are diagnosed every year in the U. S. And the largest European markets.
Despite the fact that there are multiple treatment options, There remains a high unmet medical need in both the aggressive and indolent subtypes, particularly in the relapse setting. There's essentially 2 things that are driving this unmet medical need in this space. First of all, Although rituximab containing regimens have transformed the treatment of follicular lymphoma in the first line setting, Practically all patients will relapse and in fact 40% to 60% will become refractory or develop resistance within 5 years. So there is clearly a need for additional agents that can drive remission in later lines. Secondly, follicular lymphoma, as you know, is primarily diagnosed in older people simply due to age And associated comorbidities compounded by cumulative toxicity and burden of multiple rounds of chemo of cancer treatments.
Many of these patients unfortunately fall into the elderly and frail category by the time they reach 3rd line. The proportion of elderly and frail in this setting is approximately 70%. This Is where betalutin with its unique profile can change the landscape for these patients offering durable responses balanced with excellent tolerability and maintaining quality of life all with one administration. [SPEAKER PIERRE YVES LESAICHERRE:] Diving deeper into follicular lymphoma setting, I'd like to contextualize how beta lutin's unique product profile positions it for success. So on this slide, we can see that the treatment landscape across multiple lines and across patient populations.
I'd like to draw attention to several things on this slide. So first of all, from left to right, We see that the patients in later lines of therapy tend to be quite elderly and progressively more frail. In the 3rd line setting, These patients, as mentioned previously, represent approximately 70% of the segment. If we look at the second line setting, These patients represent approximately 50% of these patients. In summary, between second and third line, A large proportion of these patients are indeed elderly and frail.
Secondly, as you can see, There are multiple treatment modalities, lots of boxes, either available or under development ranging from CAR Ts to by specific to PI3 kinases. These treatment options, however, due to safety and tolerability profiles are often limited to those patients who are still fit and therefore on the left hand side of this graph. [SPEAKER PETER BRAUDE BACHER:] You will notice that EZH2 inhibitors are portrayed here as an option. It is important to note [SPEAKER DOCTOR. DANIEL MARTINEZ VALLE:] DANIEL MARTINEZ VALLE:] That they have their greatest effect in patients with the relevant mutation, meaning the EZH2 mutation, which actually unfortunately only represents 15% of the population.
The other option that we see here [SPEAKER DOCTOR. PAUL EDGECLIFFE JOHNSON:] Pavel Nedvedev:] In this setting is rituximab single agent, which is sometimes used simply because there are not many other options that the hematologist can offer. And let's not forget many of these patients have in fact already relapsed or are refractory to rituximab, but there aren't many options. So that's why physicians go with that option. So this means that patients who are frail and have relapsed or refractory to rituximab regimens do not have many options.
This is exactly where beta luetin with its unique profile could have a very real impact for frail patients in the clinic. It offers durable responses in elderly patients who are heavily pretreated, a predictable and manageable side effect profile, all with a single dose administration. This positioning that I just shared with you clearly resonates with customers. So the efficacy seen in Limrit 3701 Part A was certainly seen as a strength. We saw approximately 70% overall response and median duration of Responsive about 13.6 months.
More specifically, we saw 32% achieve a complete response with a median duration of response of 32 months. This was seen as compelling by HemOnx in the clinic. This is then combined with The manageable safety profile, I'll be going into more details of that shortly and the simplicity of a one time treatment. So in summary, The positioning as depicted in the previous slide clearly resonates with customers when they see the Limerick Dieter 3701 Part A data. So over the next couple of slides, I'll provide a high level view of the clinical data.
So, two slides on that. And then I'll go into a little bit more detail on the safety and tolerability. And these are in fact the reason to believe for the potential for beta lutin. So Here we see a waterfall chart which summarizes the data from Limerick 3701 Part A with each bar representing a patient. The y axis is the change in tumor size as a percent of baseline.
So lines going down is good. The first conclusion we can draw is that there is a lot of surface area under the x axis. In fact, 90% of the valuable patients had a reduction in tumor size and derived a clinical benefit from a single dose administration. Secondly, beta lutein is clearly active and we see that follicular lymphoma and marginal zone lymphoma are particularly radiosensitive. On this slide, we see another perspective of the efficacy seen in relapsed refractory patients.
Here, I'd like to draw attention to the 3rd line in bold roughly in the middle of the slide where we can see that follicular lymphoma patients with 2 Or more prior therapies achieved an overall response rate of 70%. Of the 32 that had a complete response, [SPEAKER THOMAS MONROE PATTERSON:] We saw that median duration of response was a remarkable 32 months, again with a single administration. So [SPEAKER DOCTOR. PAVEL MASLOVSKIY:] Pavel Maslovskiy:] That was on efficacy. Now changing gears in terms of tolerability.
Again, the data from LIMRET-three thousand seven hundred and one Part A shows that the side effects Primarily hematological in nature. You can see this on the right hand side of the slide. These are transient and reversible drops in lab results such as platelets and white blood cells, something hematologists are clearly comfortable managing. What's remarkable And on the left hand side of the slide, what is remarkable is that this is in a population that has a median age of 68 years and is heavily pretreated. This is certainly gentle when compared to the other clinical options available for later line follicular lymphoma patients.
Now referring back to the landscape slide that I shared with you earlier. So in summary, What we saw over the last three slides is our reason to believe that betalutin offers the potential for durable responses, Particularly in relapsedrefractory, elderly and frail patients, a gentle side effect profile all within a single administration. So now let's take a look at PARADIGM. So as a reminder, as a result of the LIMIRIT-three thousand seven hundred and one Part A data that just shared with you, PARADIGM, the Phase 2b trial, was designed to determine the value of betalutin in third line follicular lymphoma patients. As previously communicated as well, the primary endpoint is overall response rates with secondary endpoints being duration of response, progression free survival, overall survival and the quality of life.
The original design was to randomize across 2 arms with differing doses. After the interim analysis last summer, the independent review committee recommended to continue only with the 4,015 arm. As a result of this, and of course in agreement with the FDA, the patient numbers were then reduced from 130 to 120. Since our last quarterly call, we've added 10 fully enrolled patients. And after we checked yesterday, We have 4 in screening, 2 of whom will be enrolled in the coming days.
Given that in Q3 of last Here, 3 patients were enrolled. And in Q4, we recruited 14. We now have a similar [SPEAKER PIERRE YVES LESAICHERRE:] Order of magnitude of patients compared to last quarter. And this is despite the significant COVID restrictions seen particularly in Europe. So this slide, I'd like to provide a little bit more detail in terms of and context on the PARADIMM trial.
[SPEAKER PIERRE YVES LESAICHERRE:] What we've seen is that the clinical trial amendments as well as the improved trial execution are clearly delivering results. So as a reminder, The amendments to the protocol expanded the inclusion criteria to allow for 2 sets of patients. The first set of patients were those who had previously received autologous stem cell transplantation and the second set of patients for those who had lower platelet counts at baseline. These two changes have allowed for a greater proportion of patients to be considered and is what brought us to this higher level of enrollment. Additionally, we of course continue to focus on a variety of initiatives that are designed to accelerate patient recruitment.
This higher level of recruitment was Despite the significant challenges that COVID restrictions have brought, especially in Q1 of this year in comparison to Q4 of last year, particularly in Europe. As you're likely aware, follicular lymphoma is an indolent disease, Meaning that even under normal circumstances, part of the clinical strategy of managing patients is to watch and wait. Now as a result of COVID, ESMO last year issued guidelines which called upon clinicians to do more watching and waiting to prevent patients from having to come into the clinic. What we have seen and has indeed been confirmed by Q1 calls With other companies that are active in the follicular lymphoma space, the number of patients suffering from follicular lymphoma coming through the clinic has dropped by about 20% to 30%. So as COVID restrictions are lifted, We expect this to have a positive effect on our continued recruitment of patients into PARADIGM.
So with all of the above considerations, We expect to complete enrollment allowing for top line results to be shared by the end of 2021. So, Upon completion of Paradigm, we have a clear regulatory strategy to gain rapid approval. So our BLA filing with the FDA for accelerated approval will be based on the PARADIGM data as well as the initiation of a confirmatory Phase 3 trial, which we intend to focus on second line patients. Our plans would be to do this during the course of 2022. It is also worth noting that the fast Track designation granted in the U.
S. Means that we have a stronger dialogue with the FDA, which we are certainly utilizing. So coming on to my last slide before handing over to Milena to cover the financials. As I'm sure you've seen in yesterday's press release, we now have additional reason to believe in the potential for betalutin in addressing the unmet medical need in the follicular lymphoma setting. So just as a reminder, ARCHER 1, A small Phase Ib trial was designed to evaluate the safety and tolerability of betalutin when used in combination with the mainstay rituximab.
The secondary objective was to evaluate the antitumor activity of this combination. The study population was in follicular lymphoma patients who had received 1 or more regimens. These are earlier lines This is an earlier line of patients to those in the PARADIGM trial. What was seen was that the excellent safety and tolerability was similar to that [SPEAKER DOCTOR. PAVEL MASLOVSKIY:] Pavel Maslovskiy:] Observed in LIMR 3701 Part A also when used in combination with rituximab.
What we also saw was that 7 out of 7 patients achieved a response, 5 of whom were complete responders. We now have Another data point confirming the activity of betalutin in patients suffering from follicular lymphoma. The key insights derived from this Trial are certainly hypothesis generating and is of course being taken into consideration as we evaluate [SPEAKER DOCTOR. PAUL EDGECLIFFE JOHNSON:] PAUL EDGECLIFFE JOHNSON:] The design of the confirmatory Phase 3 study that I mentioned earlier in second line follicular lymphoma. The design will, of course, be finalized in collaboration with experts in the lymphoma space as well as in consultation with the FDA.
So with that, I'll Pause and hand over to you, Malena. So over to you. [SPEAKER MARTIN PEREZ DE SOLAY:]
Thank you very much. Good morning, everyone. So on the next slide, you can see that we have kept the good cost control. If you look at the Q1, this year, we had $101,000,000 in spending, which is lower than last The 126. And we kept the as I said, the cost control in place.
And we, of course, still continue to spend most of the money as we should on the CMC and clinical. You can also see here that we with the cash flow, we had a minus SEK 134,000,000 which is a little bit [SPEAKER JEAN FRANCOIS VAN BOXMEER:] More than last year, but that's simply just to the fact that we have more bills to pay in this quarter. On the next slide, you can see that the cash runway, Which has now, as Jan also said, has extended into the second half twenty twenty two. And that's, of course, due to that we have the 2 Placements or the first one was the private placement in February, which gave us NOK 361,000,000 And another one, which was the repair, a very successful repair, which was SEK 61,000,000. So in total, that's SEK422,000,000 In gross, which net is SEK 395,000,000.
This means, as I said, that we have a cash into the second half twenty twenty two. With that, I would like to hand it back to you, Peter.
Thank you, Malena. So, on to our summary slide. So, in summary, we are well positioned to win. Radiopharmaceuticals clearly have a key role to play in the future of cancer therapy and we're well positioned there. Beta lutin is an important and exciting product opportunity.
In fact, one of the most attractive and advanced In this radio pharmaceutical space, we're clearly focused on completing paradigm and we target to have preliminary 3 month top line data by the end of this year. And I hope that you agree that despite the COVID challenges that we've had, we've brought The recruitment levels to another order of magnitude. And then lastly, beyond paradigm, multiple opportunities exist For us to go beyond beta lutin and we would build then on the proprietary anti CD37 franchise that we have and build upon the heritage that we have in radiopharmaceuticals. So with that, I'll stop presenting and open the floor to any questions that you may have.
Thank you, Peter. We do have Quite some questions today and I have tried to group them into some topics. [SPEAKER ANDREA LOUIS SERVRANCKX:] And then we will collect the latest arrivals in the end. First of all, a lot of questions about the progress. First question is, what is the rationale for reiterating readout Of top line data second half of twenty twenty one, when patient recruitment is significantly lower than Expectations communicated in the Q4 presentation.
Okay. This is Peter. I'll address that one and then I'll ask Marco if he has anything else to add. As was shared, if you look at The Q3 numbers that we had last year where recruitment was approximately 3%. The changes that were made, the amendments that were made and also all the efforts that went into the operational aspects of the trial last year, We have significantly improved the recruitment rate to another level.
So in Q4, we had 14 patients included. So this quarter's numbers of 10 and when you include as well the patients that are in late stage screening, so you can add another 2 because they will be included in the coming days. We're clearly at another level. No, so and that's of course within the context of what has been particularly in Europe, a very challenging environment To include patients that are in the non Hodgkin's lymphoma space, particularly follicular lymphoma, what we saw and as I shared in the presentation, What we and clinicians have seen is a significant drop of 20% to 30% of patients coming through the clinic. So within that context, The number of patients that were recruited and included in the trial is clearly at another level.
So we are at that higher level. And as particularly here in Europe, we pull out of the COVID situation, we do expect to see more patients coming through the clinic. And we do expect to be able to capture and benefit from that increased patient flow through the clinic. So Marco, do you have anything else that you want to add to that?
No, I think you covered it very well, Peter. I would only emphasize that clearly The impact of COVID restrictions in Q1 in Europe were probably higher than we had anticipated. However, we see that the impact of vaccination program are changing the landscape in many countries, starting from the U. K, Germany and Southern European Countries. So we see that the initiatives that we implemented Are really bringing a different path, a different type of patient enrollment.
And with the support Of the vaccination program and the lifting of COVID restrictions, we have great hopes that in the next Few quarters, we will be able to achieve the level the desired level of enrollment that everybody expects.
Thank you, Marco and Peter. The next question is whether it It's possible to do a top line efficacy readout around New Year even without 100 sorry, even without 120 patients enrolled at that point.
Well, let me first of all reiterate that Our intention is to complete recruitment within the timeframe foreseen. So that's clear. And the intention is to provide top line data by the end of the year. Marco, do you want to add anything else? No.
Okay.
Thank you. And how much time do you think you need from readout or top line data from Paradigm to a completed BLA for beta-eleven to be sent to the FDA.
Marco, do you want to handle that one?
Yes. Of course, in order To have validated data, so clean data that you can use for the regulatory submission, you clearly need and we mentioned this during the previous quarterly call 6 to 8 weeks, but this may not be required in terms of providing top line data. So I think You need to consider what is the reason why you are basically for what scope you are communicating the data. [SPEAKER PIERRE YVES LESAICHERRE:] But it's about 6 to 8 weeks to complete the cleaning of the data in order to be able to file them for your BLA package.
Thank you, Marco. Is there an increase in screening? And how many patients do you expect to recruit each month until readout?
As mentioned earlier, what we've seen as a result of COVID restrictions over the last quarter is that there was a pullback in the number of patients coming through the clinic. As we pull out of the COVID restrictions, those numbers will indeed increase. And again, I would like to reiterate that we confirm our expectation to be able to Complete recruitment and provide top line data by the end of the year. Mark, I don't know if you want to add anything. No, we're good.
Okay.
Okay. And can you say something about which countries show the best recruitment? And how was the distribution of recruitment for the past 3 months?
Yes. As was previously communicated in previous quarterly calls, we don't comment on recruitment by country. What we can say is that there are additional countries that are coming online. So but we won't comment on specific country numbers and evolutions within countries. Marco, anything?
No? Okay, we're good.
Good. And the next question is whether you can say something about the proportion of trial sites in Europe, higher level?
Marco, do you want
to comment?
Yes. We clearly have a higher number of sites In Europe compared to other regions in the world, whether it's the U. S. Or Asia or other regions. But this is quite normal.
Most of hematology oncology trials With any type of drugs do have the majority of sites in the European region. So, this is quite aligned to certainly my experience with a series of other oncology companies.
Thank you. Then there's another question. In order to be able to read top line data towards the end of the year, when must paradigm be completed by the latest? So another Another variation of the same question as before.
Can you repeat the question? Sorry.
Yes. In order to be able to read top line data towards the end of the year, when must Paradigm be completed by the latest?
Again, we'll I'll just reiterate that we expect to complete recruitment in such a way that we can provide top line data by the end of the year.
Thank you. Then we have a longer question that we have been asked [SPEAKER KARL HENRIK SUNDSTROM:] To read out in his whole formulation and it's about the guided 3 month readout also. Can you elaborate on how the recruitment is going to increase, Give some specific data and build some confidence for the general investor, which countries are expected to increase and why? And is it just based on severity of corona?
Okay. Marco, can you handle that one?
Yes. I think as I mentioned earlier, we clearly see the impact of vaccination program throughout Key European countries, large European countries where we have a fairly high number of sites. I'm talking about the U. K, I'm talking about Germany, talking about Italy and Spain. We feel that With the softening of the COVID restrictions, this country, which have a fairly high number of enrolling sites, We'll be able to go back to the full ability to enroll patients.
And we expect that with their strength and Contribution to enrollment and the impact of the amendment that we approved throughout the participating countries, We can go back to the expected rate of enrollment.
Thank you, Marco. With that, I think we have covered the questions that have come in, in relation to Paradigm [SPEAKER THOMAS E. SALMON BERRY GLOBAL GROUP, INC.:] Salmon Berry Global Group, Inc.:] And the data readout. We'll move to Archer. When do you expect data from Cohort 2 in the Archer study?
Marco, can you handle that?
No. The data that was communicated in the press release issued yesterday Includes the data from both cohort 1 and cohort 2. If you recall, we had 3 patients in cohort 1 And 4 patients in Cohort 2. And we felt it was appropriate to provide a comprehensive summary of both Efficacy and Safety. And as Peter highlighted in his presentation, we had 7 responses out of 7 patients.
So both patients in Cohort 1 and patients in Cohort 2 responded. And The responses are still ongoing in all of the patients and at least some of them, I think 4 or 5 of them have already reached 2 years since the administration of rituximab since the administration of beta lutein, apologies.
Thank you. And is it possible that the 2 PRs in Archer 1 after time or overtime, I guess, Can become CRs or is this very unlikely?
It's difficult to predict. Clearly, as you remember from the design of the study, these patients are on long term maintenance with And anti CD20 with rituximab, which is administered again for 2 years. So It could be that, of course, with the impact of maintenance therapy, these patients could possibly evolve, but it's very For me to address your question, I would need probably a crystal ball to address the question.
Will you actively seek a partner for the next phase of Archer?
Jan, do you want to handle the partner Question? Yes.
No, we're not going to make any specific statements regarding potential partnership discussions. So that's where you are likely to leave it at. For strategic reasons, we're not going to disclose that information at this stage.
Thank you, Jan. The last question about Archer would be, when do you expect to make a decision regarding the next step for
Sure. Yes. So maybe just as a summary with Archer 1, what we saw was again Excellent safety and tolerability that was similar to what we have seen in Limbicinib. And this is within the context of combination with rituximab. Secondly, we saw excellent data confirming that Sorry, there's a bit of noise in the background there.
I'm not sure. So clearly, the key insights that we derive from this trial Our certainly hypothesis is generating. And this is certainly being taken into consideration as we look at the Phase 3 study that we're evaluating for second line follicular lymphoma. So this is going to be feeding and informing the step that we will be taking past paradigm. And that design will, of course, be finalized together with experts in the field as well as in consultation with the FDA.
Thank you, Peter. We will move to partnerships and commercialization. The first question is, what is your strategy to get betalutin approved in MZL the fastest way possible while retaining as much as possible on the upside to the company?
Okay. Marco, do you want to comment on MZL?
Yes. As Peter highlighted in his presentation, We saw very promising data on marginal zone lymphoma patients. You recall both The waterfall and the actual response rates in the 9 marginal zone lymphoma patients. We had Considered last year, if you recall, the possibility to include an arm in the paradigm study to enroll enough marginal zone lymphoma patients to further understand the efficacy level and consider Potential development plan. But in the end, we prefer to focus on timely completion of the trial.
Clearly, marginal zone lymphoma represents an interesting opportunity. It is not as large an opportunity as follicular lymphoma. And therefore, we are still considering how we can best maximize this option from a regulatory perspective. Peter alluded to the Phase 3, which we are currently Planning to activate. It's a requirement to file for accelerated approval.
Of course, we will focus on second line follicular lymphoma. We will explore options to consider how to best move forward marginal zone. But at the time being, we have no clear Plan, but bear with us and we'll provide further details. We know marginal zone is a radiosensitive tumor And we know that beta lutein can provide marginal zone lymphoma patients with a clear benefit. But of course, [SPEAKER PETER BACHER:] We need to maximize the path to approval and therefore we still have a lot of thought to be given to this topic.
Thank you, Marco. We have some questions about partnerships again and commercial strategy. And I think, well, they are a little bit similar, but I'll try to cover it all. One question is the commercial strategy for betalutine in Asia and Europe is to establish partnership. How is this progressing?
[SPEAKER STEPHEN ROBERT BINNIE:] And same kind of question, are you are there any dialogues regarding a partnership? [SPEAKER ANDREW WIECHMANN MSCI, INC.:] And if Petalatin gets approval, would you prefer to sell the company or would you prefer to build a Sales organization and sell by yourself.
Okay. Jan, do you want to Yes.
No, for obvious like very similar to what I said before for very obvious competitive reasons, we cannot disclose specifics regarding potential discussions we are having with 1 or more parties.
Thank you, Jan. Then we have one question about financing. Will there be another capital issue this year?
As I said, We have money now going into the second half of twenty twenty two. Of course, it always depends On the pipeline and whatever we have as we said, we have money now to the completion Of the paradigm and that is of course where our focus is. Jern, I don't know whether you want to say more.
Thank you, Malene. Then we have a couple of questions about the same topic Related to and I think this goes to you, Mako. MEI Pharma recently received accelerated approval for deragents for 3L based on a sample of 91 patients. Their original population target was 130. Do you view it as possible to achieve AA based on less than 120 patients?
Can you please repeat because we know that ME Pharma informed The Street that the FDA accepted Their application for marginal zone lymphoma, so can you please repeat the question because this is what was reported in the past Few days.
Yes. I'll try once again. It says, Emmi Pharma recently Received accelerated approval for their agents for 3L based on a sample of 91 patients with an original target of 130 patients. And in light of that, do you see it possible to achieve AA based on less than 120 patients?
So maybe we'll leave the disconnect on the approval to another date. But what I can tell you And I'm speaking on behalf of my colleagues in the clinical and regulatory teams. We have had robust discussions With the FDA on several occasions during 2020 2021. When we discussed The different amendments related to new patients to be enrolled in the PARADIGNE trial Regarding the recommendation from the independent review committee to reduce the trial From 2 arms to 1 arm, on the occasion of these interactions, we also discussed quite Some level of detail, what would be the required type of efficacy and safety information to file a BLA package amenable for receiving accelerated approval. So we believe that with the data that we have collected to date, once we have completed PARADIGM and pending data And with the additional wealth of safety data collected in the other trials, we will be able to meet the expectations of the FDA.
So I hope that clarifies the question.
Thank you, Marco. And with that, I believe we have covered All the questions that have been submitted. So thank you, everyone, for sending it.
Okay. Good. Then I think there's only one slide left, and that's simply a reminder of the upcoming dates. Yes, you can see them on the screen. And thank you very much.
And I think this was, I hope you agree, a nice quarterly summary and my first one for Nordic Nanovector. So looking forward to hearing you, either later today in the coming weeks and certainly in approximately 3 months. So thank you.