Good morning everyone, and welcome to the Nordic Nanovector Q2 and First Half 2021 call. I'm Malene Brondberg, Interim CEO and CFO, and with me today I have our Chief Operating Officer, Marco Renoldi. 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 webcast live, and a recording will be made available on the Nordic Nanovector website. Questions for the Q&A session can be submitted as usual throughout the presentation through the webcast platform, and we will attempt, of course, to answer as many as those as we can. 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 risk and the uncertainty that could cause actual results to differ materially from expectations. 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 2021.
We continue to make progress announcing our PARADIGME trial with Betalutin in the third-line FL. As we get closer to the finishing line, we are thinking about, of course, how we position and prepare the company for a successful outcome. As we announced on the August 5th, we have revised the timeline for PARADIGME, and we now anticipate the preliminary three months top-line data during the first half of 2022.
We have to date enrolled 94 patients out of our 120 targeted in PARADIGME, which is up by 11 patients compared to our Q1 call at the end of May. You might recall that I said that we had low expectations for August due to it being the holiday season. We are therefore pleased to report that we have enrolled a further two 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 PARADIGME readout and into the second half of 2022.
During the first half, we also reported positive data from our combination Archer-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 Betalutin in combination with rituximab. Also demonstrated promising early signs of efficacy with all seven patients responding to the treatment, six 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 III trial of Betalutin that is required as part of the Accelerated Approval BLA filing process with the FDA. As a result, we've decided not to invest further into this trial. Lastly, we also announced that we will hold an R&D Day in Q4 to discuss Betalutin development and commercialization strategy, as well as share insights from our broader pipeline. Next slide, please.
Before we go into the operations, let me first remind you why we are here and why we're so committed to what we're doing. Non-Hodgkin lymphoma is a common cancer affecting more than 150,000 new patients every year, only considering the seven 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 a novel treatment option that can address this need. Our current focus, as you are aware, is the treatment of relapsed refractory follicular lymphoma patients. 40%-60% of these develop resistance or become refractory to rituximab, which is the mainstay of NHL treatment.
In addition, elderly and frail patients may not be suitable for another cycle of chemotherapy or one of the newly available treatments, such as the PI3K inhibitors or the CAR T-cell therapy which while effective, are associated, as you know, with high side effect burden. There are unfortunately limited options for these patients.
We believe that Betalutin can meet their need for a chemo-free effective yet tolerable treatment, and the unique, which is really unique, a 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. rituximab 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 actually what's best for the patients.
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 clusters patients by age groups. As you can see, it is clear from this chart that in the relapsed refractory setting, second 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 third line follicular lymphoma, elderly and frail patients represents approximately 65% of patients. 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.
tazemetostat, which is effective, yet only in a small fraction, approximately 15% of the third line follicular lymphoma population. Lastly, some other approved agents such as the PI3K inhibitors, which patients do not wish to take due to their toxicity. Next slide, please.
We believe this slide actually very nice conveys our aspiration, which is to ensure that Betalutin can truly fill the significant unmet need of the elderly and frail segment of the relapsed refractory follicular lymphoma patient population. As you know, starting in the third line indication, PARADIGME is designed to support the use of Betalutin in this indication, and it is our goal to then expand its use into the second line upon completion of the confirmatory phase III trial.
Based on the clinical data so far, we believe that Betalutin could deliver the durable remission these patients long for, coupled with an unmatched tolerability profile and the convenience of a one-time administration. Next slide, please. When I say customers, we mean clinical stakeholders such as hematologists, medical oncologists, and nuclear medicine specialists.
They share our conviction that Betalutin's potential bundle of benefits, one-time treatment, durable response, general 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 PARADIGME, the completion of which remain our primary focus, and we are nearing the end of the recruitment, which we of course are very pleased with. We have, compared to a year ago, managed to significantly increase the 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 trial 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 PARADIGME, and we now expect the preliminary three months data readout during the first half of 2022. Next slide, please. Looking forward, enrollment into PARADIGME is coming to an end, as suggested. We continue our efforts focused on preparing for the filing and commercialization of Betalutin.
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 completing the Process Performance Qualification campaign, which is required upon filing. This is done to document consistent quality of our clinical and commercial supplies. We are also helping our contract manufacturing partners to prepare for pre-approval inspections.
We are also making progress in strengthening our commercialization and partnering strategy and exploring all go-to-market options to enable us to capture the full potential of Betalutin in the different geographic regions. From a regulatory perspective, our goal is to file a Biologics License Application, also called BLA, which the FDA based on the data generated by the PARADIGME trial.
It is our current intention to apply for Accelerated Approval, and this will, of course, require us to have a phase III confirmatory trial stated at the time of the BLA submission. Next slide, please. Now I will take you through the key financial highlights for the second quarter and the first half of 2021. 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, as you can see, a total operating expense for Q2 coming in at NOK 103.9 million, which you can, if you look at the slide here, and you can see that it's roughly the same as Q1 2021. 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 2021 decreased to NOK 205.1 million from NOK 239.3 million in the same period of 2020. This decrease is due to our, again, careful management of financial resources, which are focused on completing PARADIGME and other development activities needed to support the regulatory filing. Turning to the next slide, where you can see our cash position, which was NOK 450 million at the end of June 2021.
This is, of course, following the successful private placement and the repair offering, which raised approximately NOK 422 million. Here, I would actually like to say thank you to all our shareholders for their continued support. This gives us a cash runway into the second half of 2022 beyond the expected preliminary data readout from PARADIGME, which is an important thing to mention, of course. Onto the next slide, where I would just be wrapping up and let me just conclude on our outlook.
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. Betalutin is also one of the most attractive and advanced radiopharmaceuticals in clinical development, an area of increasing interest in the pharmaceutical industry.
As I said, we are focused on and determined to complete PARADIGME as quickly as possible so we can report the preliminary three-month top-line data during first half 2022. This is a key milestone, and I really mean a key milestone, for Nordic Nanovector, and we are really all working hard to achieve this. In parallel, we continue the workstream needed to support the filing and the commercialization of Betalutin.
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 Betalutin and build on both our proprietary anti-CD37 antibody franchise and our established heritage in radiopharmaceuticals. We plan to talk more, as you know, about these opportunities at our R&D Day in Q4. Next slide, please. Thank you again for your attention.
Before we finish and move on to the Q3 presentation in the November 18th, 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&D Day, which we expect to set in due course. 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.
Once again, thank you very much for your attention, and also thank you very much for all your support and your continued sending questions. Now I would like to open the Q&A session where I know Marco will join me. I will hand it over to you, David, please.
Thank you, Malene. Let me start with the first question. When do you expect to employ a permanent CEO?
Well, thank you for that question. It is, as you know, the Board that hires a CEO, and the only thing we can say today is that the board is in the process. As Jan said last time, they are evaluating candidates. 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 PARADIGME?
Yes. Marco, if I start and then you can maybe jump in. 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. It's possible in some countries at the moment, and in others it's not. It's not even country by country, it's also different regions by countries that are more open or closed. Those are some of the initiatives that we're taking and continue to take.
Here I would actually like to say a very big thank you to all our employees, but 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've anything 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 Betalutin, which require the treatment to be handled in a specific setting. 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 wear a Nordic Nanovector flag, we've also increased the number of scientific liaison of our contract research organization. We have had a large number of medical staff that 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. As I said, we feel a strong pipeline with potential patients. Of course, nothing is never given, as you know, with everything in this world, but we think it looks good. As also you can see, it is the third quarter in a row where we actually report a +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. The pipeline of patients under consideration that we have today is the largest we have ever seen. We are very confident. As you said, the pipeline of patients under consideration doesn't mean that they've all consented. Not all of them are or will enter screening. We're very confident.
Thank you, Marco. What is the level of recruitment that you anticipate is required to be able to report the three-month top line data in H1 2022?
As you can see today we have 94, and the target is 120. The difference, what we expect every month is not something we will go into because as you have seen in the past, 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.
I think you covered it 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 our last call.
Yes. I think data in particular, independent review of the scans are being progressed as we move forward. I think what happens is at the end of the last month, so when the patients of the last month will be enrolled, there will be a period of probably three, four weeks for the last patients to be reviewed and cleaned and to make sure we collect the independent assessment. I think it's almost parallel to the completion, to the enrollment and dosing of the last patient. Again, the four weeks time for the collection of 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?
As I said, the preliminary data readout is in the first half, and we have money going into the second half.
Thank you, Malene. Just a couple more questions. What is the preliminary median duration of response for the Archer-1 study?
I can take that. Yes. As Malene pointed out, and I think it's also in today's press release, six out of seven patients who responded in the Archer-1 trial are still in remission. We will, of course, deliver all of the efficacy proxy, including duration of response when the study is fully reported and presented at a medical conference.
What we can share today is what type of checkpoint these six patients who are still in remission have already achieved. Three 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 six months checkpoint, being in remission.
I hope you would concur with us that these are very good results and seeing that not only all of the patients are in remission, but that three 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. Final question, there are a couple of them, are essentially could you provide an update on the partnering situation?
I can take that, Malene.
Yeah.
We continue to explore different options for the best go-to-market strategy, and we are open to all options. 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 Betalutin 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. We believe these options could also bring additional funds into the business, resulting in a lower need for external financing rounds.
Thank you, Marco. That concludes all the questions we've received this morning.
Fantastic. Okay. Well, lovely. Thank you so much. Before we say goodbye, I actually 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 Nanovector. We have a lot of hard working, and I can tell you everyone is bringing out their A game.
Thank you to all the employees, and we have so much talent, and it is a pleasure to work with everyone. Thanks to the leadership team as well. As you can hear, it is teamwork. Marco and I are here together on the presentation. With that, thank you so much, and we will, as I said, in due course, announce the date for the upcoming R&D Day which will be in Q4. Have a good day, and also a very good weekend.
Thank you very much. With that, we conclude today's call.