Very much, Nas, and welcome everyone to the BNVICA interim report presentation. So if you move to Slide number 2, we have the names of the participants. Besides me here today, I have our Executive Vice President and CFO, Cecilia Dreeving. Cecilia?
Good morning, everyone.
And also our Clinical Development Director, Matthias Beichlief.
Good morning.
And moving to the next slide, the Slide number 3 with the agenda. I'm going to make a short introduction to Vivica, what we do, and I'll present the highlights for the report. Matthias is going to take us through the latest study results from clinical trials that we have been performed during this period. And then I'll talk a little bit about what's ahead of us and what we're doing right now, the commercialization plan and activities, where we are and what you can expect next. Cecile will talk about the financials.
And finally, we'll summarize and have the opportunity Slide 4, the short introduction about bivica. So bivica develops and commercializes blood based biomarker assays to monitor to pre monitoring on modern cancer therapies. And the product, Divitum, is an assay that can accurately measuring cell proliferation from a simple blood sample of a patient. And as you all know, proliferation and cancer is closely related. The product has in clinical several clinical trials with some of the leading key opinion leaders, the best cancer oncologists in the world, proving its capabilities to early evaluate therapy effectiveness in metastatic breast cancer and other polycancer areas.
This is also something that Matthias will elaborate a little bit more on as we have the latest results to discuss in this conference. Our initial focus is within the metastatic breast cancer area, where we are working hard in order to launch the product on the U. S. Market during 2021. And of course, the product itself has great benefits for patients, but also for payers in order to manage the treatments better and with a more individualized treatment schedule.
If we move to the next one, Slide 5. We were supposed to have a summary of the events during the Q2 and events after the end of quarter. One major milestone for the company was the submission of the 510 application. And leading up to that was the completion of the clinical validation phase, where we met all the criteria that we have defined prior to starting the validation. The clinical validation and the analytical validation that have been performed previously and communicated before summer is what the major part of the application and the application itself was submitted by end of September.
We also made a new share issue a targeted share issue of, in total, SEK 148,000,000. And we got both some new investors and some larger previous investor that took part in the share issue. And we are very grateful for the confidence that the shows us and the great interest for taking part in this share issue. And after the period sorry, at the end after submitting the 510 application, we got feedback from the FDA that they currently are handling a lot of COVID-nineteen related applications that has emergency priority for BIVIKA that resulted in a 90 day pause in the handling of the application from the FDA. A month later, we got a confirmation that they now see 60 days.
So they are sticking to the original plan of 90 days pause, which is comforting for us. Despite this occasion, we've been able to run our business pretty unaffected in this difficult time of COVID. So we're grateful for that as well. And then after the end of period, we presented or will be presenting at the ongoing San Antonio Breast Cancer Symposium for results from full clinical trials within the metastatic breast cancer area. And that is something that Matthias will elaborate a little bit since this is a milestone for us and very important for the activities going forward when commercializing and launching the product.
So if we can flip to the next slide summarizing these 4. And Matthias, maybe you can take us through the different clinical trials and the results of those.
Yes, of course, Andrew. Thank you. It's my pleasure to walk you through our trials that will be presented at this meeting. And it actually kicks off today, the San Antonio Breast Cancer Symposium. This is sort of the world's cutting edge scientific program in breast cancer.
So it's a great scene for us to be at. And we are, as Anders already alluded on, on stage with 4 different clinical trials. And this is, of course, a clinical trial program and outcome that is highly valued by us and any biomarker company. And the results are strong, but they are also the outcome of our many years of dedicated work with a laser focused aim to provide unique clinical value in a specific patient group. And that patient group is what you see on this slide, metastatic breast cancer patients, specifically the application to monitor these patients and to early evaluate the efficacy of their therapy.
So the trial that I will be highlighting today is the SWOG study, which is also our FDA application trial and the clinical validation study. It is the PISIA study, which is our first planned prospective trial that kicked off in 2015 already. It is a study from University of Nebraska and Washington University looking at the new dosing of a CDK4six inhibitor, which is part of the standard therapy today. And it is a study from the Mayo Clinic, which is a genomic study, sort of a future study where divotome is included as a benchmark to measure again. So if we then go to the next slide.
This slide actually summarizes our trial coding to date. And the early trials that we did here in order to establish our pivotal and application to monitor metastatic breast cancer, we did already back in 2013 together with the Karolinska. So ever since then, we have been very committed to provide unique value for dividend in this area. And the first proof of concept study made it possible for us then initiate new collaborations on the other side of the pond in U. S.
And those three trials will be part of the trials that are presented at the Tenantechanical Breast Cancer Symposium. So up until now, we have published 6 trials in metastatic breast cancer in full and these four trials now at San Antonio will be published as abstracts. So all in all, we now have 14 clinical trials within breast cancer from early stage to late stages, and that includes more than 2,300 patients. And DIVITAM has also been in focus for 3 editorials summarizing the results and value for assay. And the applications addressed are the prognostic application, looking at recurrence in early breast cancer, but also progression and survival in the metastatic setting.
And for monitoring, the key thing is to get quick feedback on treatment efficacy. We can then move to the next slide. So the first study I want to highlight that we presented in San Antonio is the SWOG study. This is a very large trial and it shows that Divitum is a strong prognostic biomarker for progression free survival and overall survival. Samples are taken at baseline and then at cycles 2, 3, 4 7, and that is, of course, transferable approximately to month 2, 3, 4 and 7.
So all in all, 1726 samples were analyzed in this trial with 100% evaluation rate. And that is important because not all liquid biomarkers have evaluation rates. For example, CA-fifteen-three, it's only possible to evaluate approximately 80% of patients. But in this case, we were able to analyze 100% of all samples in the study. So the highlights of the results are that studies at baseline at a subsequent time point is associated with worse prognosis in these newly diagnosed patients.
And it is also important that you have a biomarker that is independent from baseline. So if patients come into the clinic, they are diagnosed, but then you might not you might the physician might forget to get the sample. Then it's also important that the biomarker can provide information also in cycle 2, 3, 4 and 7. And that is exactly what we have provided evidence for in this trial. So findings also demonstrate that patients with low dividend values at baseline can be relatively well on single agent therapy, and they may not need combination therapy.
And that was a new finding here that Pivotal also can predict and be a tool for selecting therapy already when patients are diagnosed here. So this has been a very pleasant finding in this trial. It is also predictive capacity of this. Application. If we then move to the next slide, which is the PIFIA trial.
This is the first prospective dividend study where we planned together with IBCA CHI or the International Breast Cancer Study Group and the Breast International Group. This study has also been funded by the European Commission through our Horizon 2020 grant, the BioValidate project that we were awarded in 2015. So in this study, 122 patients have been enrolled and they were enrolled at 19 centers in Belgium, Italy and U. K. And the study addresses standard therapy of an endocrine therapy in combination with the CDK4six inhibitors.
And what is exciting here is that samples are taken at baseline and then at 2 4 weeks. And the results demonstrate that patients who get a suppression demonstrated by Divitum at 2 weeks, they have a significantly better progression free survival. They have a significant better outcome at 6 months. And those patients have an 85% progression free survival at 6 months compared to 17% of those who don't get suppression. So that means that DIVASSAN can quickly identify patients with poor prognosis and resistance to therapy.
And the authors also conclude that dividend may be used as a novel biomarker to select patients for alternative treatment modalities. Okay. So then we go to the next study. There are a lot of study and a lot of science here for you. But this is also an important trial because one of the challenges of providing drugs today for this patient group is, of course, also tolerability here.
And at the University of Nebraska and Washington University, they decided to embark on a journey to look at the new dosing of a drug called palbociclib, a CDK4 inhibitor, which is part of the standard therapy to date, but they were not happy with the tolerability of this drug. So they decided to do a new dosing schedule, giving the drug for 5 days on and 2 days off instead of 3 weeks on and 1 week off. And they were successful in this because this dosing schedule showed better tolerability. But it was also important for them to have a biomarker that could provide evidence that this dosing schedule also provided strong efficacy data and also had a biomarker that can identify which patients who responded to this new therapy. And what's interesting with this trial too is that there is a lot of samples in this trial and they are taking at baseline 2 4 weeks and then every 3 months for more than 2 years.
So these patients were followed for a long time with many samples. And the results demonstrate that patients with a response on no disease progression, they have significantly lower dividend values at baseline than patients with progressive disease. But during the serial monitoring of these patients, a rise in dividend levels predicted disease progression more than 3 months prior to imaging progression, also highlighting the capacity of dividend to sort of conclude on what is coming many, many months ahead of what is able to what you are able to detect with imaging today. So the dividend levels at baseline and on therapy dynamics demonstrate promising results for response prediction and monitoring of this new standard therapy in metastatic transcatheter and called the cycle. Okay.
So we then move on to the final trial that will be presented, which is a genomic trial, which is, of course, part of the future because if you want to learn about this disease and improve both regarding therapies, but also our knowledge about how to monitor and how to get early signals on resistance development of tumors, then it's important that we increase our knowledge on the genomic side of things. And in this trial at the Mayo Clinic, the first 32 patients in this study have been analyzed and samples are taken then at baseline and after 2 months. And the aim of the study is to look at the predictive capacity of DIVITAM and provide a comprehensive genomic assessment in order to identify new genomic variants and pathways that are associated with an early decline in TK. And then, of course, correlate that to patient outcome. So, the results that we presented at the Congress demonstrate the patients with high or low dividend values, they have different genomic expressions, which is, of course, interesting here.
And the pattern between dividend levels and patients' genomic expression profiles may be important for future monitoring of metastatic breast cancer to test new treatments to overcome the resistance that eventually occur for this chronic disease. So the study is ongoing and it will report updated data from additional time points and greater number of patients. In nature. Okay. And then we can go to the next slide because all of this data and the solid clinical trial program that Bivica have developed together with our key opinion leaders across the world have generated a lot of interest in dividend.
And these five trials are some of the ones I want to highlight on the work that's ongoing at the moment. And you might have followed Johns Hopkins because they are also a leading university regarding statistics around COVID, but they're also a very, very successful university in oncology and we are very happy to collaborate with them on the trial looking at the early identification of progression in this area. And also, recent study that we have initiated collaboration on just 2 weeks ago that we highlighted in the press release is a collaboration with the Christa Hospital in U. K. And also 4 Swedish centers will be part of this.
And that study will also look at the early identification of progression added with the optimal time points to sample for a dividend evaluation, the course of therapy. And then we have a study with the Karolinska Institutet called Cedix, which is a preoperative trial looking at the new adjuvant response marker, give it a much new adjuvant response marker during preoperative treatment. And then there's an independent trial from us called Bio Italia that is performed by Novartis, quite large trial, almost 300 patients. And that trial will have as a name to early identify disease progression. And then we're doing a proof of concept study, which is interesting in a way that it's looking at different combination of drugs.
It is palbociclib in combination with chemotherapy. So we are also addressing patients that are not hormonal responsive in this study. So the data from this ongoing trial program will, of course, support our submission to the FDA and what we are aiming at being an approval next year. So the data from this program will start to produce results from next year, some hopefully in good timing with the U. S.
Approval. But it will, of course, also be important for the reimbursement and for later on the clinical uptake. Okay, Anders, I think I'll put a stop there, and I'll hand the word back to you.
Thank you, Matthias, very much. And you will, of course, be around also if for taking questions around these clinical collaborations and results from them. So if we move on to the next slide, we have a high level slide describing our path, the key activities in order to commercialize and launch the product. And I'll give you an update where we stand on these different activities. And first of all, it's the development of the product.
And you could say that, that has been completed since quite some time now. And the product has, as I earlier mentioned, also been validated and that was important basis for the FDA submission. Moving on to the clinical development, which Matthias has covered. In a way, you can say it's completed because we have most of the data that we think we requires in order to launch the product. We have, as you've seen, added now several trials that add significant number of patients, also increases the data on U.
S. Patients. We have added prospective data and we have strong results on CDK4six inhibitors and on in comparison with the current best practice, which is imaging. So that adds a lot of strength to our evidence of the value of the product. But we will, of course, continue with, as Matthias showed, ongoing trials to strengthen the evidence further.
When it comes to the regulatory pathway, yes, that's the 510 ks and you can see that that's also completed from our part at least. We've made a submission, and we're eager to see the feedback from the FDA, which we expect that they will start assessing our application beginning next year. In parallel, we will also submit for CE marking using the IVDD process in Europe. Key activities that we are working with right now is commercial partnering with a lab partner that can offer this Buildium as a service and also have an efficient and strong sales force that can be complementary to our offering. And also be a partner when it comes to the next area, reimbursement and to get paid for the product.
And reimbursement and guidelines goes very closely hand in hand. So we're working also with that, and I will give a specific update on where we stand within that. And in order to launch the product, we tie everything together and we have a communication plan together with our key opinion leaders when it's time for launching the product, which we expect to do mid next year. If we move to the next one, I have a breakdown over the reimbursement area. That's been an area with high intensity of a lot of progress this period.
And of course, with the data that Matthias just presented, it complements and is a strong foundation also for this area. And one important milestone for us will be inclusion in the guidelines. And the most important ones are the NCCN and ASCO guidelines. And we are now initiating those discussions and starting to plan for that to happen. In parallel with that, we have initiated a project in order to develop a budget impact model and the deliverable there will be a value to us here to be used in the discussions with the different payers to be able to prove the value for the product for the payers.
And of course, that will also be we can use a lot of the data and results from our clinical development program, which Matthias presented. Going forward, with that, we also need a strategy for coding and coverage, which we also developed, how we will work initially with a non specific code. And then over time, we'll get a specific code, and we have a plan for that. And that also goes for the different types of payers that we would like to interact with and define a percent for payment and price levels. And we will, of course, start with the early adopters.
Some have a lower threshold for required evidence, and those will be our early adopters, which we will interact with initially, and then we will expand the coverage over time. And that goes also hand in hand with our distribution model. Initially, we will have a pre centralized model, so we can ethically manage this payment process and getting into the reimbursement system and we'll work together with our lab partner to do this. And over time, when we've established ourselves in the reimbursement system, we can widen the distribution and have a more distributed model. And a very good thing here for us is that the enzyme that we are measuring is stable and we're able to transport it, allowing for this kind of a centralized model.
That's the update on guidelines and reimbursement. I'll move on to the next one. So here's a slide how we intend to launch on different geographical markets and an estimation of the market potential for the product. And as you can see, our ambition is to introduce the test on the U. S.
Market being the biggest and most advanced and trend setting market, which also has a reimbursement system 1, although complex, but one reimbursement system that we'll introduce the product on. We've also estimated the market potential per market, and we've done that based on market research where we have interviewed payers and key opinion leader oncologists to get input for use of products and price levels, where we have received feedback on the U. S. Market around $300 to $500 per test. And on the Nordic and UP markets, we estimate about half the price levels.
That combined with the number of patients living with the disease is what's made up the figures you see on this slide. We estimate that on each market that we will enter, that we will be able to gain 15% of this market potential 3 years after launch of product. And so we start with U. S, and it's planned for midyear next year. And the 2nd market will enter, and we will we believe we'll be able to reuse a lot of the assets being developed on for the U.
S. Launch is the biggest top 5 biggest European market and the Nordic markets. And for that, we will also work with partners on the different countries on the European market. So this is the first application, the metastatic breast cancer area. And then one should bear in mind that this is just a small portion of the total potential.
Also, this is the first geographies. There's a great potential to expand. As you saw on Mattias' slides, we already have data from and ongoing trials within the locally advanced area, which we expect the current treatments being used within metastatic breast cancer, where we have strong data to enter. And we're also interested to expand outside of the breast cancer area where we already have data in large cancer areas like lung cancer and gastrointestinal cancers, for instance. And you see the same unmet need for Divitum as we see within the metastatic breast cancer area.
So if we move to the next slide, we are into the financials. And I'll ask Cecilia if you could walk us through that.
Thank you, Anders. We'll start with the sales numbers. Sales you have declared are to customers in the research market and as such, they vary considerably from one period to the next. And since our customers is pharma companies and they face relatively large orders for the purpose of analyzing an entire clinical study at a time, it differs a lot. This sentiment can clearly be seen when comparing with last year's sales.
And our focus now is to take a return to the clinical market, and that will probably generate soon with more regular sales, but not until after regulatory approval. Now we leave the same chart and look at the cash balance. As you can see, the cash balance has increased significantly. We ended the Q1 with a share issue of €148,000,000 as Anders told you in the beginning, and the issue cost was about 5% of that. And after issue cost, the cash balance increased by SEK 141,000,000.
And at the end of the second quarter, we had SEK 162,000,000 cash and that will cover our operations more than 20 4 months. The run rate is now about 3,300,000 for the 1st 6 months. And going forward, this will increase when we invest in the launch activities. The higher level of spend compared to last year is a bit less attributable to the dividend TKA project associated with the submission of the 510 application through FDA and the preparation for commercialization. The organization is growing, and the average number of patients is now 21 compared to last year's 'seventeen.
And we will continue to grow the organization preparing for the commercialization of dividend. And the increase has been in line with what we have done, and it has been, in fact, slightly lower. And that's about it. Turning over to Anders. Thank you, Cecilia.
And also here, we're able to question about that in the Q and A session. To summarize this, I think we have a very interesting product with high potential that can address an important unmet need currently within metastatic breast cancer to improve monitoring of treatments. And it's also an unmet need outside the metastatic breast cancer area and but our initial focus is within metastatic breast cancer. We also have strong collaborations with some of the leading key opinion leaders and academic research centers in the world within the field. And together with them, we have completed several clinical trials with great outcome, which will be the basis for the entire commercialization process.
And the market potential, we estimate to about $400,000,000 to $700,000,000 for these initial markets within metastatic breast cancers. And that's U. S. And the big European countries and the Nordics initially. And the upcoming their assessment in quarter their assessment in quarter 1 and so we can see an approval in Q2 next year.
And in parallel with that, we're working to get an agreement with a commercial partner, a lab, a mid tier lab in the U. S, which will be our partner for the U. S. Launch, which will be done in parallel with or right after FDA approval. And soon after that, we expect to receive the first U.
S. Reimbursement on the U. S. Market, and we'll work to build a wider and wider coverage reimbursement coverage within the U. S.
Market. And we're looking through collaborations with partner within Europe to enter the first European market by end of 2021. So we have very exciting times ahead of us during next year and onwards when we are about to bring Divitum to the benefit of the breast cancer patients in all these markets, which we look forward to very much. Thank you very much. That was our presentation.
And we are now open for
questions. Thank you. Our first question comes from the line of Rickard Anders from ABG. Please go ahead.
Good morning and congrats to the recent developments here and thank you for taking my questions. So first of all, if I've understood things correctly, looking at the commercialization side here, you've indicated that you in the longer term could enter an agreement with a larger commercial partner or perhaps several lab partners in the U. S. Is this correct? And what do you expect you need to get in place before expanding your commercial footprint in the U.
S? Would it be broader guideline inclusions or reimbursement coverage? Or what steps should we expect for you to expand that commercial presence in the U. S, if you will?
Yeah. I think all of those will help. So the reason for a more centralized model initially is to be able to control and handle the interface with the payers for reimbursement, which is key success factor. When you have established processes with more and more payers, we can widen the distribution model. And that goes also hand in hand with expectation of an increased sales.
And for the development of the reimbursement sales also, the factors you mentioned, inclusions in guidelines, for instance, is a factor that drives sales uptake and reimbursement coverage and in the end also commercial collaborations.
I don't
feel happy with that answer, Riccard.
Yes, of course. Thanks. And just as a clarification there, in terms of these lab partners, are they usually keen on getting exclusivity? Or is it a trade off between sort of a revenue split, if you will, that they are willing to leave exclusivity open? Do you understand a bit what I'm looking for in terms of their terms in the agreement?
Yes. Yes. Thanks.
Yes. So we are not looking to enter exclusive agreements initially. No, that is not our strategy. So we're looking to work with non exclusive agreements. And we believe, from the discussion we've had so far, that that's a way forward that will work
well. Great. And just looking at the caseload of COVID-nineteen cases in the U. S. And the continued rush here for testing applications, are you seeing any worries that your 90 days FDA delay could be extended?
Or how should we think about that potential risk on the timeline?
Yes. I think it's comforting that we have received feedback. The FDA promised monthly feedback, and we received that about a month after the first communication. And they said initially said 90 days. And in the second feedback, they said you can expect us to start this in 60 days.
They're not giving any guarantees, but it's a positive sign at least.
Great, great. Sounds promising. And just a final question here on the prognostic use case and particularly looking at the particularly looking at
the abstracts here from the San Antonio Breast Cancer Symposium.
Isn't it usually the case that patient response is poorer in a faster growing tumor versus slower growing tumor, I. E. That TK1 sort of at baseline answers an already clear question in terms of a prediction of outcome in the patients. So that I. E, a higher TK1 activity sort of per definition leads to a poor response?
Or how should we think about the prognostic use case data?
Matthias, is this something you can help us sort out? Yes. I mean, that's a
good question, Riccard. But the thing is that you, of course, need to establish that. I think we have established a dividend. It's the greatest technology to measure that and to conclude that. And also, if you're going to bring that knowledge into the application of monitoring these patients going forward, it is great to have a baseline value and to conclude that.
And we have also demonstrated the dividend is an independent biomarker here, irrespective of what you find with other markers, what you find with other risk and prognostic factors. So I think we are on a very solid ground and we have a very strong evidence that dividend can provide unique data on its own. And of course, the prognostic outcome is very, very important, specifically looking at progression, but also looking at overall survival, of course. But then you can also add to that the predictive novelization now seem to get from this first evidence from the SWOG trial that it might also be important that you establish these values with a specific cutoff. And here, dividend is completely unique towards everything else you compare against because we've established our own cutoffs in our own solid trials.
You must use dividend in order to gain that knowledge. So if you are above or below a specific cutoff, that is very, very important to you because that means that you have the opportunity to get the patient to answer to a specific drug, of course. So that is also important, not only the prognostic perspective.
Sure. Great. And just final there on the prognostic. Do you think that the prognostic use case will require larger prospective mortality based outcome studies to reach guideline inclusion and uptake? Or do you think that other endpoints such as progression and these types of endpoints are enough, if you will, to gain traction and uptake in that sort of use case?
Okay. That was a few questions in one, Rikka. The first one was regulatory wise. If we believe that the prognostic claim requires prospective trials and more patients. Is that correct?
No. Basically, just in terms of getting guideline inclusion and broader uptake, if you believe that larger prospective trials, which look at mortality, will be needed to reach guideline inclusion and commercial uptake and coverage from the insurance companies and so forth.
Okay. I understand. Okay. That's a good question. And I think if we can in prospective trials and we will have that data over time, if we can prove that by managing treatments using Divitum, you can have a better survival outcome, that's of course fantastic.
And it's not unrealistic, but we don't have those data yet. We will have those that data. And you can, of course, speculate in what the results will be and rather not to. But our go to market strategy and yes, the commercialization process and launch project and everything is not taking that it's not a requirement for that. It could be an that comes on top of the data that we have.
Do you
understand what I mean? We are making that claim. We could over time add that when we have that data, but we haven't based our go to market process on that because that would add a couple of years on the time line.
Sure, sure. Right. So that might be a few years after that.
But we continue yes, we continue doing clinical trials that will add data and add possibility to add claims when it comes to intended use, yes.
Sure. Great. That's all for me. I'll get back in the queue. Thank you very much for taking my questions and congrats once again.
Thank you,
Next question comes from the line of Niklas Elenhallmer from Redeye. Please go ahead.
Hello. Thank you. Thank you for a very thorough presentation. I actually have a bit of follow-up question to the last
But
when do you think it's realistic to expect to be included in any guidelines, the current clinical evidence, if it's
sufficient, so to speak? Yes. We haven't given that way that precise because we are just initiating those discussions now. And we don't see it as a requirement for the first the early adopters when it comes to payers because we have we believe we have significant data and together with the 510 clearance for start, initiating those discussions, especially if we add the health economics that we're also working with and expect to have done before we get the guideline inclusion. But we don't yeah, but we think also we can use a lot of the data that we have to get included in the guidelines and we expect the NCCN to be the first one, but we haven't set a date for that.
But we'll come back to that when we have had these initial discussions. But it's in within the time period when we say we will get this 15% market share, we within a 3 year period. We've assumed that within that period, we will have guideline inclusion. So that's a wrap. Okay.
Thank you then. More
detail on that, we'll come back to. Yeah.
Okay. So regarding sort of the launch activities and the U. S. Commercial organization, are you standing a ramp up right now? Are you hiring now?
Or are you such contingent on the FDA process, so to speak?
Yes, that's a good question. We are actually ramping up now. And Sue will present some key hires that will be important to drive the work in the U. S. So yes, we are strengthening a U.
S. Organization according to the plans that we have communicated previously that we will have a small but strong and specialized U. S. Organization that can work effectively with our partners and with reimbursement.
Okay. Thank you.
Thank you, Niklas.
And as there are no further questions, I'll hand it back to the speakers for closing remarks.
Well, thank you very much for the interest and the great question. And we look forward to come back as we progress and move into a very exciting 2021 for Baivica. Thank you.