Good morning, everyone, and welcome to the Nordic Nanovex Q2 and First Half twenty twenty one Call. I'm Marlene Bruntberg, Interim CEO and CFO. And with me today, I have our Chief Operating Officer, Marco Rinaldi. Today's earnings release report and the slides for this call are available on our website at nordicnanovector.com. Please note this call is being webcasted live and a recording will be made available on the Nordic Nanovector website.
Questions for the Q and A session can be submitted as usually throughout the presentation through the webcast platform and we will attempt of was to add as many as those. Please turn to the next slide. As always, we need to go through this slide. We need to advise you that this conference call will contain forward looking statements and such forward looking statements are subject to risks and the uncertainty that could cause actual results to differ materially from expectations and more information can be found on this slide. Please turn to the next slide.
Turning to the highlights for the second quarter and first half twenty twenty one, we continue to make progress announcing our paradigm triangle bitter luting in the 3rd line FL. As we get closer to the finishing line, we are thinking about, of course, how we position and prepare the company for successful outcome. As we announced on the 5th August, we have revised the timeline from Paradigm And we now anticipate the preliminary 3 months top line data during the first half of twenty twenty two. We have to date enrolled 94 patients out of our 120 targeted in paradigm, which is up by 11 patients compared to our Q1 call at the end of May. At our call on 5th August, we reported 92 patients.
And you might recall that I said that we had low expectations for August due to it being the holiday season. We're therefore pleased to report that we have enrolled a further 2 patients in August, which despite the restrictions due to COVID and the delta variant is an improvement compared to August last year where we actually had no recruited patients. Following a fundraising during the first half of the year, we have now cash That leads us a cash runway that takes us beyond the expected paradigm readout and into the second half of twenty twenty two. During the first half, we also reported positive data from our combination ARTSER 1 trial in the second line of FL patients. We are encouraged by the result of this small study, which confirmed the attractive safety profile of baselujin in combination with rituximab, also demonstrated promising early signs of efficacy with all 7 patients responding to the treatment, 6 of whom are still in remission.
We believe that data and insight from this trial will be important to the design of the confirmatory Phase 3 trial with bistelutin that is required as part of the accelerated BLA filing process with the FDA. As a result, we decided not to invest further into this one. Lastly, we also announced that we will hold an R and D day in Q4 to discuss betelution development and commercialization strategy as well as share insights from our border pipeline. Next slide, please. So before we go into the operations, let me first remind you why we are here and why we are So committed to what we are doing.
So non Hodgkin lymphoma is a common cancer affecting more than 150 1,000 new patients every year, only considering 7 largest pharma markets. Despite the availability of multiple treatment options, NHL is still associated with a high unmet medical need both as regards indolent and aggressive subtypes. Our mission is to deliver another treatment option that can address this need. Our current focus, as you are aware is the treatment of relapsedrefractory follicular lymphoma patients. 40% to 60% Of these developed resistant or become refractory to rituximab, which is the mainstay of NHL treatment.
In addition, elderly and frail patients may not be suitable for another site or chemotherapy or one of the newly available treatments such as the PI kinase inhibitors or the CAR T cell therapy, which while effective are associated, as you know, with high side effect burden. So there are unfortunately limited options for these patients. We believe that Betelution can meet their need for a chemo-three effective yet tolerable treatment and the unique which is really unique and one time administration further contributes to improve their quality of life. Next slide please. Sorry, I just lost it here.
As I highlighted earlier, there are a number of treatment options for follicular lymphoma patients. Mituximab with chemotherapy is, as you know, the standard of care in first line. While moving into second and third line, There are no clear consensus of action what's best for the patients. And on this slide, we've tried to capture the different options in the matrix where the vertical axis breaks down the follicular lymphoma subtypes by line of therapy while the horizontal axis cluster patients by age groups. So as you can see, it is clear from this chart that they're In the relapsed refractory setting, 2nd and third line, there are few therapeutic options.
And those that show clinical activity are burdened by high side effect profile, which makes their use unsuitable in elderly and frail patients. It is important to note that in the 3rd line follicular lymphoma, elderly and frail patients represents approximately 65 of percent of patients. So then left for them is far from, as you know, ideal, In essence, only rituximab as a single agent, which has a modest efficacy and will have no activity in rituximab refractory patients. Tesametuzat, which is effective yet only in a small fraction, approximately 15% of the 3rd line follicular lymphoma population. Lastly, some other approved agents such as the PI kinase inhibitors, which patients do not wish to take due to their toxicity.
Next slide please. So we believe this slide actually very nice conveys our aspiration, which is to ensure that basileutin can truly fill the significant unmet need of the elderly and frail segment of the relapsed refractive follicular lymphoma patient population. As you know, starting in the 3rd line indication, paradigm is designed to support the use of betelution in this indication. And it is our goal to then expand its use into the second line upon completion of the CONFIRMSO Phase 3 trial. Based on the clinical data so far, We believe that Betelution could deliver the durable remission these patients long form coupled with an unmatched to our build to the profitability profile and the convenience of a one time administration.
Next slide, please. Our aspiration is shared by many customers we have interviewed. And when I say customers, we mean clinical stakeholders such as hematologists, medical oncologists and nuclear medicine specialists. They share our conviction that Betelution's potential bundle of benefits, one time treatment, durable response, Tiemun tolerability profile sets it apart from available competitors and makes it the ideal treatment option for frail and elderly patients who as a result of their comorbidities cannot or do not want to receive treatments that will further compromise their life quality. Next slide please.
Now to the shorter Update on Paradigm, the completion of which remain our primary focus and we are nearing the end of the recruitment, which we of course are very pleased We have compared to a year ago managed to significantly increase enrollment rate, which is driven by the improvement of the trial design and the many initiatives we've taken. A good example is our new targeted social media campaign to raise awareness of our tribe that has started to pay off and we are now seeing a good pipeline of potential patients, in fact better than we have seen before. This is extremely encouraging given our efforts have been impacted, As you know, by the spread of the COVID delta variant and continuing restrictions that are still causing problems and affecting our ability to screen, enroll and treat new patients. However, We are not where we wanted or expected to be, which was the reason we communicated we have revised the timeline for Paradigm And we now expect the preliminary 3 months data readout during the first half twenty twenty two. Next slide please.
Looking forward, Enrollment into Paradigm is coming to an end as suggested and we continue our efforts focused on preparing for the filing and commercialization of betelution. And we have I can tell you, we have a lot to do. For example, For the CMC section of the filing, we are currently working on completion of the process performance qualification campaign, which is required upon filing. This is done to document consistent quality of our clinical and commercial supplies. We're also helping our contract manufacturing partners to prepare for preapproval inspections.
We're also making progress in strengthening our commercialization and partnering strategy and exploring all go to market option to enable us to capture the full potential of Bitelution in the different geographic regions. From a regulatory perspective, our goal is to find a biological license application also called BLA, which is the FDA which the FDA based on the data generated by the paradigm trial. It is our current intention to apply for accelerated approval And this will of course require us to have a phase 3 confirmatory trial stated at the time of the BLA submission. Next slide please. So now I will take you through the key financial highlights quarter and the first half of twenty twenty one.
We continue our cost control and we of course continue To control our costs carefully, as you know, this has been a focus throughout years, but particularly, of course, the last year with a as you can see, a total operating expense for Q2 coming in at 103,900,000 which you can if you look at the slide here, and you can see that it's roughly the same as Q1 2021. And also if you go back to the Q4 for 2020 and it is less compared to the same period for 2020. The total operating expenses for the first half twenty twenty one decreased to $205,100,000 from $239,300,000 in the same period of 2020. This decrease is due to our, again, careful management of financial resources, which are focused on completing paradigm and other development activities needed to support the regulatory filing. So Turning to the next slide, where you can see our cash position, which was SEK 450,000,000 at the end of June 2021.
This is of course following the successful private placement and the repair offering, which raised approximately SEK 422,000,000. Here I would actually like to say thank you to all our shareholders for the continued support. This gives us a cash runway into the second half of twenty twenty two beyond the Expected preliminary data readout from Paradigm, which is an important thing to mention, of course. So on to the next slide where I would just be wrapping up and let me just conclude on our outlook. So I would just like to emphasize that we strongly believe that betalutin is an exciting product opportunity with its attractive safety and efficacy profile from a single one time administration and potential for use across the NHL population.
Viteleucine is also one of the most attractive and advanced rate of pharmaceuticals in clinical development, an area of increasing interest in the pharmaceutical industry. As I said, we are focused on and determined to complete Paradigm as quickly as possible. So we can report the preliminary 3 months top line data during first half twenty twenty two. This is a key milestone and I really mean a key milestone for Nordic Nanovex. And we are really all working hard to achieve this.
In parallel, we continue the work stream needed to support the filing and the commercialization of Bitelution. These include evaluating partner opportunities designed to maximize the value we can create from this exciting and potentially important product. Finally, we continue the work towards evaluating the multiple opportunities to expand the market for beta lutin and build on both our proprietary anti CD37 antibody franchise and our established heritage is radiopharmaceuticals. We plan to talk more as you know about these opportunities at our R and D Day in Q4. Next slide please.
So thank you again for your attention. And before we finish and move on to the Q3 presentation. In the 18th November, as you can see, is our next event. I also want to just say that we need to have of course a date set for our R and D Day, which we expect to set in due course. And we really hope that this event can be an event that you can attend in person because it would be nice to meet all of you again in Oslo.
So once again, thank you very much for your attention and also thank you very much for all your support and your continued sending questions. And now I would like to open the Q and A session where I know Marco will join me. So I will hand it over to you, David, please.
Thank you, Malina. Let me start with the first question. When do you expect to employ a permanent CEO?
Well, that's a thank you for that question. It is as you know, it's the board that hires a CEO. And the only thing we can say today is that we are in the or the board is in the process. And as Jan said Last time, he is or they are evaluating candidates, so as soon as possible.
Okay. Thank you. Could you elaborate on what type of initiatives have been taking place at clinical sites and local clinical sites to speed up Recruitment in paradigm.
Yes. So, Marco, if I start And then you can maybe jump in. So as I said, we have in some not in all countries, but we have initiated a social media campaign, which has given us a good funnel of Potential patients that could be hopefully some of them may be enrolled, not all of them are eligible And that is a very strong initiative. Other things that we are doing, which is, of course, that we are going out to visit the sites, which of course is difficult in this environment. And it's possible in some countries at the moment and in others it's not.
And it's not even country by country. It's also different regions by countries that are more open or closed. So those are some of the initiatives that we're taking and continue to take. And here, I would actually like to say a very big thank you to with all our employees. Of course, the team that's working on that have been working really, really hard in these times because it is really difficult still out there.
Marco, I don't know if you have any further to add.
Thank you, Malene. I'd like maybe to add a couple of other initiatives. We have partnered with companies that are tasked with accelerating the patient enrollment in clinical trials, In particular, with companies that facilitate referral of patients for treatments such as beta lutein, Which require the treatment to be handled in a specific setting. And again, we have partnered with a company that basically Identified potential referrals in centers that were close to the investigational sites So that we could maximize the potential identification of patient, not necessarily reaching the investigational site. In addition, we increased the number of customer facing medical teams in addition to the medical science liaison, Which of course were Nordic Nanovector flag.
We have also increased the number of Scientific liaison of our contract research organization. So we have had a large number of medical staff [SPEAKER JEAN FRANCOIS HENRIK SUNDSTROM:] They were in close contact with investigators and reminded of the opportunity to potentially enroll patients.
Thank you, Marco.
Thank you. The next question is how many patients do you have in screening?
We don't give that number. And but as I said, we do have a And we feel a strong pipeline and with potential patients. Of course, it's not You can never nothing is never given, as you know, with everything in this world, but We think it looks good. And as also you can see, it is the 3rd quarter in a row where we actually report a plus 10 patients, which we believe is a very good sign and is a good sign that despite and this on top of the delta variant that it is actually working, the initiatives that we have taken. Marco, I don't know if you have anything to add.
No, you covered it very well. I have to concur, we the pipeline of patients under consideration that we have today It's the largest we have ever seen. So we are very confident. As you said, the pipeline of patient under consideration doesn't mean that they've all So not all of them are or will enter screening, but we're very confident.
Thank you, Marco. What is the level of recruitment that you anticipate is required to be able to report the 3 month top line data in H1 twenty twenty two.
So as you can see today, we have 94 And the target is 120. And the difference, What we expect every month is not something we will go into because as you have seen in the past, it is It's very, very hard to predict and especially with the delta variant. As I said, we are doing everything that we can And we will continue to update every quarter on where we are and be as transparent as we can. I don't know, Marco, if you have any further comments.
No, I think you covered the year very well, Malene. I think if we continue to show the type of recruitment of the last three quarters in a row, So an average of 12 patients per quarter, I think then achieving that target is not only doable, but Very, very realistic.
Thank you, Marco. Can you give any more granularity On how long after completing recruitment results will be ready to be released?
Marco, I think you answered that on the on our last call.
Yes. I think Data in particular independent review of the scans are being progressed as we move forward. So I think what happens is At the end of the last month, so when the last the patients of the last month will be enrolled, there will be a period of probably 3, 4 weeks for the last Patients to be reviewed and cleaned and to make sure we collect the independent assessment. But I think it's almost parallel To the completion, to the enrollment and dosing of the last patient. And again, the 4 weeks' time for the collection The independent review of the scans will only affect the last four patients.
Thank you, Marco. Do you anticipate to complete the readout before raising additional capital? If so, how confident are you that this will be possible given the current timeline?
So as I said, the preliminary data readout is in the first half and we have money going into the second half.
Thank you, Molina. Just a couple more questions. What is the preliminary median duration of response for the ARCHER study?
I can take that. Yes. So as Malene Pointed out, and I think it's also in today's press release, 6 out of 7 patients who responded in the ARCHARD trial are Still in remission, we will of course deliver all of the efficacy products including duration of response from the studies fully reported And presented at a medical conference. But what we can share today is what Type of checkpoint, these 6 patients were still in remission have already achieved. So 3 patients have basically passed the 24 months checkpoints, still being in remission.
One patient has passed the 18 months checkpoint still being in remission. One patient has passed the 12 months checkpoint still being in remission. And one patient has passed the 6 months checkpoint being in remission. So I think I hope you would concur with us These are very good results and seeing that not only all of the patients are in remission, but 3 of them Have already passed successfully. The 24 months checkpoint is an excellent result.
With the type of tolerability that we see from this combination.
Thank you very much, Marco. And Final question, there are a couple of them, are essentially, could you provide an update on the partnering situation?
I can take that, Malena. We continue to explore [SPEAKER JEAN FRANCOIS PRUNEAU:] Different options for the best go to market strategy. And we are open to all options. And to that purpose, we have ongoing dialogues with several interested parties. Of course, We have a priority and the priority is to choose the option that will enable our company To realize the value potential of beta lutein and to deliver this medicine To all patients who can benefit from it, while at the same time, of course, ensuring the highest return for shareholders.
As you can imagine, the options we are considering include both A standalone commercialization, but also regional and or multi regional and global partnership. And we believe these options could also bring additional funds into the business resulting in a lower need For external financing brands.
Thank you, Marco. And that concludes all the questions we've received this morning.
Fantastic. Okay. Well, lovely. Thank you so much. Before we say goodbye, I I just want to say, first of all, thank you to all the shareholders, of course, for the continued support, but also a big thank you to the team at Nordic Nanovex.
We have a lot of hard working and I can tell you everyone is bringing out their A game. So thank you to all the employees. And we have so much talent and it is a pleasure to work with everyone. And thanks to the leadership team as well. As you can hear, it is Teamwork, Marco and I are here together on the presentation.
So with that, Thank you so much. And we will, as I said, in due course announce the date for the upcoming R and D day in the which will be in Q4. Have a good day and also a very good weekend. Thank you very much. And with that, we conclude today's call.