Ladies and gentlemen, welcome to the Biovica International Teleconference Q3 2020/2021. For the first part of this call, all participants will be in a listen-only mode, and afterwards, there will be a question- and- answer session. Today, I am pleased to present CEO Anders Rylander and CFO Cecilia Driving. Speakers, please begin. Thanks very much, Keith. Welcome everyone to our interim report presentation. If we move to the next slide, you'll see that it will be me and Cecilia Driving, our CFO, that will perform the presentation. If we move to the next slide after that, you'll see the agenda. I will start with a short introduction of Biovica. We will go through the highlights for the third quarter in our fiscal year, which we're now presenting. Cecilia will go through the financials, and we will end with a summary and a Q&A where you will be able to ask us questions. We also have had questions coming by mail before that we'll start with. That's the agenda for today. If we move on to the next slide, just a very short background about the company, what we do. Biovica develops and commercialize blood-based biomarker assays with the purpose to improve monitoring of modern cancer therapies. I'll get that little bit to how we do that. We do that through our biomarker assay, DiviTum, stands for dividing tumor, which is an assay for measuring cell proliferation. We have strong clinical documentation that demonstrates the capabilities of the assays in order to do so. The beneficiaries of this is of course the patients that can get feedback if they're on an effective treatment or not, or otherwise can switch to an effective treatment. Also, payers and healthcare providers that are paying for these treatments, and of course, would like to have effective treatments for those great investments. If we move on to the next slide, there's a schematic picture of how the method works and how the product. The technology is that with our biomarker assay from a blood sample from the patient, can measure an enzyme which is active in cell proliferation process. It's very closely related to cell proliferation. As you all know, cancer is defined by uncontrolled cell proliferation. In many clinical trials, it's been evident that this correlates very well to the aggressiveness of the disease. It's very prognostic. Also, during a treatment, can give early feedback if the patient is responding to the treatment or not. In the picture, it illustrates how DiviTum works in connection with imaging being the standard method being used today for monitoring of the patients in the metastatic setting, where you compare size of the tumors before and during treatment. That requires a couple of months before you can do that evaluation. We've shown in clinical trials with DiviTum that we already after two weeks can get feedback if the treatment is sufficient or not. That's from a simple blood test, which of course provides great benefits. The product in itself, it's a kit where you mix reagents with the blood sample from the patients, and then you get a readout and a value of the cell proliferation rate that you can use for monitoring of the treatment. The product is developed on a standard platform, so it's easy to implement. Yeah, you can read more on our homepage about the technology and all the publications supporting it there. Moving on to the next one. We have a summary of the significant events during this third quarter in our fiscal year. The first bullet is for a study that was presented on the world's biggest breast cancer conference, breast cancer being our focus area, it was very important. This was something we went through pretty throughout on the last presentation, I won't cover that more. The other three I will cover. The news, two studies, well, both the U.K. one which also involves sites in Sweden that have started, the Italian study. Both of these are within breast cancer, I will cover that on the next page. We also have positive news from the FDA, that they have resumed our FDA or 510(k) application by end of January, I'll comment a little bit about that process as well on the upcoming slides. After the end of the period, we announced that the Karolinska University Hospital has published collaboration or a clinical trial that they've done on their ProMIX study where they used DiviTum to get the feedback on treatment efficiency. I'll go through that as well on the coming slide. All right, moving on to the next one. That slide covers the two new trials that we have communicated that we have started. These trials are both prospective trial. That means that patients will be enrolled, followed over time, and several DiviTum samples will be analyzed during the course of their treatment. It will be an observational trial and give very important information, both for the treating oncologists, but also for Biovica as a company. The first one in the U.K., it's performed by The Christie Hospital. It's 100 patients. It's a CDK4/6 inhibitor, which is becoming more and more the standard treatment within hormone-positive breast cancer, it's our focus area for the product as well. In that trial, they're assessing the hypothesis that you could reduce imaging using serial lab samples with DiviTum, thereby early detect resistance to this CDK4/6 inhibitor based on biomarker feedback. This is a sweet spot that we would call clinical utility, we're very grateful for this trial. Similar with the TEIRESIAS trial at the Prato Hospital in Italy, where we have 150 patients that will be followed during their treatment, it's the same kind of treatment, CDK4/6 inhibitor. The hypothesis is that using biomarkers, DiviTum specifically, that you can make treatment decisions to offer best possible treatment for the patients. You can read more about these on the clinical trials. You have the NCT numbers with more information on details about the trial. This is also, since we are looking to enter the European market, and these are key geographies. It also adds, especially in the U.K., to our key opinion leader network, which is really important. Moving on to the next slide. That was the ProMIX clinical trial that we announced the other week, that it has been published. It's a collaboration with the Karolinska Institutet and Karolinska University Hospital since many years. The collaboration was actually initiated in 2013, and it's been involving a lot of oncologists, key opinion leaders. It's over 20 authors on this paper that have been involved. The patients have been followed over 10 years, so it's a long follow-up after those initial lab samples taken and analyzed by DiviTum. This is interesting, yeah, for that long follow-up, of course, and that we're being able to predict outcome already 10 years ahead, over a 10-year period. Also, since this is outside the metastatic breast cancer area, this is locally advanced, where these patients get neoadjuvant treatment. It's interesting because it's an area where we are looking to expand after an initial introduction of the product within the metastatic area. This is the next step for us as we see it. Of course, having data supporting the value of the product in that area becomes then of course very important. This will add another 30% to the market potential. We have additional trials ongoing, and we'll generate more data within this area. It's of course a good first step. In this trial, we also were compared, this has been done before, but with the today's standard way of measuring cell proliferation today, the Ki-67 marker. Which is a tissue-based marker. Of course, it's a great advantage that you can do the same thing with a lab-based marker. We were able to see that the two markers correlated with each other. That was the ProMIX trial, a collaboration with Karolinska, and we're very grateful to see those positive results. Moving on to the next slide. As a summary of the FDA 510(k) application, and just to give you some background about that. The 510 (k) clearance is required in order to launch the product for clinical use and market the product for clinical use in the U.S., being the number one market for us, our focus market, but also the biggest market. It's a really important process, and we submitted our application by end of September last year, and we got a lead reviewer assigned. We received feedback about a month later that the FDA had paused all 510 (k) applications that was not EUA applications. That means using the emergency process due to COVID. The FDA prioritized COVID assays and put everything else on hold, including ours. Despite that, we got the feedback that we cleared the first toll gate and was given the substantive review status by mid of November. The applications were still on hold, and the lead reviewer was reassigned to other COVID-related processes. By end of January, we received very positive news. As one of few applications, they were restarting ours, so we got a new lead reviewer assigned, and the substantive review has commenced again. The process is moving forward, and we have interacted with the FDA and replied to all the questions, given all the information that they have required. That's good. If it would be their normal timeline, we would expect to have a decision before start of summer vacation. FDA has given the feedback, although we have started the process, we don't commit yet to our normal process and timeline due to the COVID situation. We have communicated externally that we are aiming for a decision before the end of quarter three this year. We're very grateful that we're progressing, and it seems really good. That is the status update about the FDA process. Moving on to the next one. The FDA process is not the only thing we do in order to commercialize the assay in the product on the U.S. Market, which is our immediate goal. There's a lot of ongoing activities, and here's a summary of some of those. One, of course, is to strengthen the U.S. team that is performing a lot of this work, and the latest addition is Amy Williams. She was recruited from Novartis, and she's located in Boston. Started in February. She has a background at Novartis, exactly within this field. She has been working within breast cancer, developing breast cancer treatments from Novartis, including the CDK4/6 and part of the launch process for launching new therapies. She has very relevant experience, a lot of long experience with oncology and breast cancer and these types of treatment and keeping a leader network. Amy will be working with our U.S. oncologists, which also will be our key customer important to reach out to. That's very important for us, and we will continuously add additional key resources to the U.S. team. Another important area is the reimbursement and the pricing strategy, and we made progress there as well. We've developed a budget impact model targeted towards the payers based on the results that we have from our clinical trial program within breast cancer. That data has now been compiled into this model, which will be presented at an upcoming health economy conference. It's already been submitted. It will also be used in the upcoming payer advisory board discussion that is planned. We're now starting to interact with the payers in that process, in the reimbursement process. In parallel with that, we've had, in January, a key opinion leader advisory board as well, in order to get essential feedback that will be worked into our messaging and the launch of the product. A patient advisory board to do the same thing for patient group is also being planned and conducted here in the coming months. We're moving forward within that area as well. When it comes to commercial partnerships, I would say this is the area where we have been most affected by the pandemic situation. That is because of our prospective partners, which is the laboratories in the U.S., the clinical laboratories, have to a great extent shifted focus for the last 12 months to do COVID testing to a very great extent and haven't had so much other focus. We see a lot of positive signs here as well, both U.S. in general, where their vaccination program is progressing really well, and the new president has set an objective that they should celebrate 4th of July as normal. They will be back to normal celebrate by then, and it seems like they might be able to achieve that, especially since they have now 74 million people that has received their first vaccination shot by now. That is positive news for us as well because it increases our capacity on those clinical labs that we're discussing with. Also, we've made progress due to the results that we recently presented on San Antonio, the big breast cancer conference, and that's the fact that our FDA process has been restarted, and also that we have some of our key opinion leaders that has been engaged and also helped us in this process. We're progressing here as well, and our objective is to have this collaboration in place or there's an agreement in place when, we get the FDA approval in third quarter. The last area I want to comment is sales to the research use only area. Before 510(k) approval, we cannot sell for clinical use, but we can sell the product for research use only, which we do. We've seen an increase here from customers, and the customers are pharma companies primarily. Pharma but also academic centers, but primarily pharma that are using the product during their clinical development, getting early feedback if the treatment is efficient, both for new treatments or for existing treatments in order to expand into new areas where they combine it with other types of drugs. The two orders, we received two rather large orders, but we shipped only partially this quarter. We'll continue. Proof of concept trials that could also lead to additional orders going forward. This is also a good sign that the results from the clinical trials that we've seen will improve the value of the product is generating sales also in the research use only area. Although the biggest potential is of course, the clinical use, but still this could also open up for partnerships with pharma, for example, companion diagnostic products, which is our ambition as well. Yes. Moving on to the next one. We're going to financial, and I will hand the word over to Cecilia. Thank you, Anders. I will try to pick up on what you just said about the sales in the quarter. As Anders said, we are in the research use only area. Right now, the customers are buying for research use only and during this phase for clinical trials and using the kit for clinical trials. We don't expect to get any continuous sales until we reach the clinical market, and that will be after launch. During the third quarter, we had SEK 1.4 million in sales, for the nine months it's almost SEK 1.8 million. Most of the sales in the quarter is attributable to the first partial deliveries on two major orders that came in during the quarter. It is one existing customer and also one new customer. It's always very exciting to see that customers come back and new ones coming in. I will switch over to the cash balance now. We started the year with only SEK 41 million in cash. During the first quarter we made a directed share issue, and after issue costs, we increased with SEK 141 million in cash and ended the second quarter with SEK 162 million. After nine months, we have SEK 155 million in cash, and we see that we are well capitalized ahead of commercialization in the U.S. and Europe. The cash assets are sufficient for more than two years of operation. Expected sales increase not included in that, we expect to increase sales after launch. The expenses have been growing, but not that much yet, they will, of course, grow more in the coming months when we add some more people in the organization, especially on the sales side. The average number of employees is now 20 compared to last year's 16. The increase is in line with what has been planned, actually slightly lower right now, but we will catch up. I will hand over to you, Anders. We apologise for this technical difficulty, we will play hold music until we have resolved the issue. We thank you for your patience, we now have the speakers back online and the call will now resume. Thank you, Anders. Please go ahead. Thank you. I don't know what happened. There was some technical issue there. I'll just start from scratch here on the summary slide because I don't know where I lost you. Yeah, we have a product with great potential that can address unmet need for personalized treatment within metastatic cancer in general, and metastatic breast cancer specifically, which is our first focus area. The potential for that first focus area is $400 million-$700 million. The geographies are the U.S. market, the top five European markets, including the Nordics, and the Japanese market. The potential has been defined through market research, where payers have been interviewed for value and price sensitivity, and oncologists have been interviewed for the process of using the product. Beyond that initial application, the locally advanced breast cancer, we think, is a natural interesting next step, which will add about 30% additional, 30%-40% market potential. As you remember, the ProMIX trial that I presented earlier is an evidence of that we have proof of concept with that area as well. We are looking to expand into other cancer areas as well as a step after that. I think we have a key strength with our collaborations with world- leading key opinion leaders and oncologists. Together with them, we have created a strong foundation with our clinical results that will be the basis for this commercialization process that we're in the middle in. It will be important for the regulatory process and for reimbursement and in the end sales uptake. The upcoming milestones to look out for is the same as been communicated before. We expect to have our 510(k) approval and by that do our U.S. launch the third quarter this year. Before end of this year, we expect to have our first reimbursement in the U.S. We also, before end of this year, launch the product on the first European geography as well. That was the presentation, and we'll now go to question and answers. I think, Cecilia, you had received some already. Yes. We have received some questions and would like to take the opportunity to answer them here before we open for questions from the audience. Anders, the first question is, what kind of competition will DiviTum TKa encounter in the field of monitoring of metastatic breast cancer? Yeah. Of course, very good question. I think you have to understand what's being used there today. Currently, imaging is the standard method being used and also are in the U.S. guidelines. It's CT scans, bone scans, MRI, and PET scans. Expensive technology, which has also great benefits in other areas than just only monitoring cancer. Here we believe we have a strong value proposition with a blood-based assay that also we've shown can give feedback already after two weeks. The normal procedure today is that you do these scans after three, four months. There are also blood-based markers out there, and in the guidelines today is, within breast cancer, are CA 15-3, CEA are the dominant one. Still, they're not used standalone and they're not used routinely. They're sometimes used, sometimes not. Here we have with the clinical data that we have generated and is still with the processes in our clinical trials in the pipeline will generate, we think we have a very good opportunity to outperform them and become the standard blood-based marker for cancer monitoring. There are also others called CTC, circulating tumor cells, but those have primarily been used within other applications. We don't see as a direct competitor. It's more for early detection of recurrence rather than monitoring on treatment. Also very promising, and there's a lot of companies now with super high evaluation, although they're in the early setting as well as Biovica on the market. However, they have focused more on other applications like being diagnostic, that is finding cancer, identify diagnosing cancer, being predictive, that is giving information before treatment. Also, during adjuvant treatment, the early phase, when you have removed the tumor surgically and then follow using ctDNA to see if there's recurrence, basically. We don't see those as competitors within the monitoring field either. They haven't focused on that, and I think we have some pretty significant advantages within that field because we don't require near as much blood volumes than ctDNA. You need a lot of volume to be able to do those analysis. With DiviTum, you only require a fraction of that. We also have cost advantages compared to those. The last category would be other cell-free circulation assays. I think the major one is Ki-67, as I mentioned, and also as you saw in that ProMIX trial, we correlate with that, with a great advantage that we're blood-based and not biopsy-based. Within the monitoring field, which is also one of the strong reasons why we have targeted that field, we believe that we have a really strong position competition-wise. Okay. I have another question for you, and that is if interventional data is needed for commercialization. No, we don't believe so. Maybe we should first start to define what is interventional data. Interventional trial, interventional data is when you're acting on the outcome of the assay. We're already doing observational trials, example is the two trials presented here that was being initiated, and there's more to come in that area as well. Those, and with the combination of the data that we already have, we believe is a great starting point for, say, quite a few of the payers in the U.S. we expect to accept the data that we already have. If we're going to reach the targets that we have set out, that is to get 15% of the total market potential three years after launch, we need to complement with interventional data as well. Hence, we're in discussion, and we'll be presenting those kind of collaborations as well coming. No, it's not required for commercialization, but it will help us reach the targets that we have set up. Thank you. Now we will hand over and open up to Keith and open up for questions. Thank you. Ladies and gentlemen, if you have an audio line question for the speakers, please press zero one on your telephone keypad now. If you wish to withdraw your question, you may do so by pressing zero two to cancel. Once again, if you have a question for our speakers on the audio line, please press zero one on your telephone keypad now. Our first question comes from the line of Rickard Anderkrans of ABG Sundal Collier. Please go ahead. Your line is now open. Good morning, Anders, Cecilia, and Mattias, and thank you for taking my questions. First here, you mentioned in the report that you've received orders from pharma companies using DiviTum when developing new cancer drugs. Is this an area you expect that will increase significantly once the FDA clearance is in place potentially here? Or are these European customers? How should we think about that opportunity going forward? Hello, Rickard. Thank you for your question. We think the 510(k) approval is important also in regards to pharma. It's a quality stamp, sort of, that we can take the assay through regulatory approval. Especially with that opportunity, that opens up the opportunity to do partnership projects. That's what we're looking into, which is Henrik Winther's background, and that with the objective that it should eventually lead to companion diagnostics collaborations. Because the pharma partner, it's a risk associated with the diagnostic test, it's important that the diagnostic partner has a track record of being able to get the product through the regulatory process. That's why that's an important milestone in that collaboration, in that setting with pharma. I don't want to speculate if it will increase. Yeah, over time it will, but we haven't made an estimate that we've communicated. Are you happy with that answer, Rickard? Yeah. Sure. Thanks a lot, Anders. You spoke a little bit about it, but expanding DiviTum's indications or intended use from monitoring to prognostic, how long do you believe that process will take? Is that a more competitive setting or a more- Yeah commercially challenging setting, would be interesting to hear as well. Yes. Okay. That's a really good question. First of all, the first expansion to declare here is we see that we're still in a monitoring category. Even if we go to locally advanced breast cancer, for instance, like in the ProMIX trial, we're still monitoring. We're still in the monitoring space. If you go into, for instance, local breast cancer, we would then enter into the more prognostic area. We have also data from, to date, two different trials within that setting of over 800 patients. We have data on that area as well. However, you run into a high level of competition, as you said. You would be head-to-head against, for instance, Oncotype DX and MammaPrint and those prognostic assays within breast cancer, which has been very successful. I think there's a great demand for that kind of a product here, especially as Oncotype DX is not available in Europe. We have the advantage that we are using this in a blood sample, not on biopsy. Yeah, it's interesting, but it's a one step further away. You should, of course, realize that the competition is tougher than in the monitoring area. Sure. Thanks a lot, Anders. You spoke a little bit about this regarding potential for interventional study here with the DiviTum. Can you communicate on the timeline when you can expect such a study to be started? Can you also communicate potentially how long such a study would take to perform in your estimates currently? Yeah. I can give you rough estimates. We're in discussion on that kind of trials already, so you can expect to see it during this year at least. Time for that is that it will take, I don't know. I should be a bit careful there. You need to have enough events basically, and on average it takes two years for 50% of the population to progress. It's going to take maybe two years to summarize the results, just based on those facts. Yeah. We think this is the normal way of doing it for diagnostic companies. If you look at the Exagen as an example, when they launched it, they launched without interventional trial and they complemented because you would like to get your cash flow going, and then with the complement, with the interventional trial, to further strengthen your value proposition and increase getting market shares and so on. Yeah, I think that's best practice to do that as well and not wait for everything to be in place and then launch. Sure. I think also. Yeah. Yeah. Yeah. Sure. Just a final question from my side. Could you please clarify the commercialization path and perhaps- especially interesting in the pharma collaboration there to build out new products, collaboration with pharma where you have biomarkers, which is more specifically tailored towards the mechanism of action for that drug. Yeah, the PCR product has advantages, but the ELISA product is a really good easily be automated on like a Tecan ELISA platform with the plate reader. That will take us far, and we can add the PCR product over time and gain some further advantages. Sure. Thank you very much for that, Anders. Have a great day, and thanks for taking my questions. Thank you, Rickard. Thank you. Our next question comes from the line of Niklas Elmhammer of Redeye. Please go ahead. Your line is now open. Yes. Hello. Thank you. It's just regarding where you are getting the clearance in Q3 and performing the launch. Can you tell me a little bit about your activities and how much you said you were adding personnel and how much you plan to add this year? Yeah. We have previously communicated that we foresee a team of about 10 people in the U.S. by end of this fiscal year. We still stick to that plan. The latest addition is Amy. She has a kind of combination of a scientific and commercial profile, being a PhD within this field, but also a lot of experience from Novartis launching this kind of product. A great addition. What we will be adding is more commercially focused co- resources. That is the next step, and we'll announce that pretty soon. Still the objective of about 10 people organization by end of this fiscal year. Oh, sorry. Yeah, the next, I think, in a year roughly from now is still our objective. Okay. What about the Europe and other regions? Yeah. The plan still stands there as well that we will enter the first European country before end of this year. You can also expect to see commercial resources being enrolled for that path as well. Okay. Great. Thank you. I was also, as you published the results from the ProMIX study. Yeah was just a little bit curious, these are promising results, but was a bit curious about how you see the use in the chemotherapy setting of TK1 behaves somewhat differently here. Yeah. That's very good of you point out, because that trial was on chemotherapy. I think it's still very valuable because it proves the concept in that locally advanced setting. It's actually a repeat we've had from U.S. trials from, for example, Washington University with Cynthia Ma was also on a locally advanced setting. Now we have repeated that U.S. trial was on CDK4/6, but this was on chemotherapy, an older type of therapy. We see that the big opportunity here is when the CDK4/6 treatment is moving into that locally advanced setting, especially since we're building with more results going forward. We expect to see the CDK4/6 usage expanding to that field as well. There's a difference between CDK4/6 and chemotherapy because CDK4/6 lowers cell proliferation or TKa levels from day one if they're effective. Chemotherapy, that it's not actually inhibit cell growth, it kills fast-growing cells. You get a spike, like with many biomarkers. With TK, you get an initial spike. The more cells that are being killed, the more TK is released to the bloodstream. That is actually also indicative if the treatment is efficient or not according to the ProMIX results. Did you understand that, or was it too complex, Niklas? No, I think, yeah. You can use that spike, but if over time that spike wash out, you will see that lower cell proliferation is a good prognostic indicator. Yeah. Okay. Yeah. Great. Thank you. Yeah. From that, there's many reasons why we focus on CDK4/6. One is that it's more and more becoming the standard treatment. The other one is that it's better suited because you don't have to think about those spikes. It's very straightforward. If the reduction in cell proliferation measured by TK, that's good feedback. Of course, not stronger from that, but the health economy, these treatments are priced at very high levels compared to chemotherapy. Okay. Thank you. Thank you. Thank you. Our next question comes from the line of Dan Akschuti of Pareto Securities. Please go ahead. Your line is now open. Hi, everyone, and thank you for taking my question. There were already a lot of good questions before, but I have a follow-up on kind of the commercial strategy in the U.S. It's a great catch that you have there with Amy Williams from Novartis, and I think that is something we see that is often a bit underestimated or, let's say, not done well in the beginning, and I think your setup is quite good. How do you come to the 10 FTEs, and would you consider building maybe a bit of a stronger, bigger force there to really ensure a fast market uptake since you do have incredible data sets already. I don't think you need any more data to convince anyone of the utility of your test. I think you need probably to push into the clinics you already are in contact with, and also others. Hello, Dan. Thank you for your question. See if I can break it down to a few questions. First of all, when it comes to our organization. Yeah, we're not certain that 10 is our end state. 10 is where we are aiming for by end of this fiscal year that we start in beginning of May. In April next year, we are aiming for such an organization. About 50% of that will be commercial profiles, and the rest of the organization, the other 50%, will be like Amy, scientific and commercial in combination. That could be also experience within reimbursement, and being able to engage with oncologists and payers and so on. Of course, if it can accelerate sales, we will invest in a bigger organization. This needs to be done also in collaboration and we plan together with our partner. We haven't signed a partner agreement. We should be careful to commit to the account because that's something we need to plan and work out a strategy in combination with our partner that also have sales resources. That will be an important factor when selecting the partner. Is that okay as for your staffing? Yes. Yeah. Okay. Yeah. Yeah. Good that you appreciate Amy's profile. I agree. I'm super happy for that recruitment and the experience that she brings is fantastic, and the personality. Thank you. Another question. It's great to see that you're preparing for launch and also at the same time preparing for the expansion and what you showed on slide seven, this is building on this NHS study on the Pfizer Mayo Clinic study that you have already published of 55 patients, where you show that you could detect 80.6 days median earlier than by RECIST criteria. Are you just building Do you think you need that, or is it just opportunistic as there is a demand for the test since you kind of showed that already in? Which one are you talking about on slide seven? The NHS study. Okay on slide seven. Yeah. Because- Okay. Yeah. Going back, I'm grateful you say that the evidence you already have is convincing. I agree. I think D-shot is really strengthening our evidence. Also, the discussion with interventional studies, this is very close to interventional studies. This is observational, so we'll get important data. You could say that we have, if you're going to forcome our budget impact model that we will be presenting later, we have two value drivers you could say, or value levers. The first one is to reduce imaging, and the second one is to reduce futile therapy. In the NHS, the Christie trial, they're looking a lot to reduce imaging. In the Italian trial, they're looking if we can push CDK4/6 inhibitors forward to second line. They're using TKa as part of that decision process. Not that they will make those decisions, that's why we all call it interventional, but they will have different arms. We will get information about TKa baseline values from the different arms that we can get the essential information for both those two very important areas for us. Does that? Okay, thank you. Yep. Yeah. This actually adds, and we will be taking more samples than ever before in these two trials. Serial samples for patients. It will add to our data a lot. Okay, thank you. A bit more to CMC, did you manage to expand your lab facilities and the lyophilizers? Did you upscale the lyophilizer, or did you just add a second and third device to do that and to ensure that you can really supply the commercial supply to a level? Yeah. The sound is a little bit, but I think I repeat your question to see if I understood it correctly. I understand the question, if we are prepared for launch in terms of supply of kits and production process and so forth. I remember you had only one lyophilizer, I think. I think that was a while ago, but I'm just curious if you have installed more than that or if you're about to, or if you're going for a bigger one and concluded the process development for that so that you can ensure supplying the commercial demand. Okay. We still only have one facility. We're at the moment very happy with that. It's also cost aspect. We work with our processes, so we have developed our product, but also our production processes as part of this FDA submission process. We also expect the FDA to visit us to audit our processes, so we're ready for that. That's one of the quality aspect. When it comes to the volume aspect, we are convinced that with our current facility, we can meet the volumes that we expect in the coming at least 18-24 months in our current facility. However, we don't have a failover capability in place. It's a single point of failure in some places. In order to mitigate that risk, we will manufacture, so we have kits on the shelf. We will overproduce initially, and then over time, we will add a second production line so we have failover, and we can also both increase volumes and increase uptime service levels. Yeah, we're following our production plan as we have laid them out. Okay. When could we expect this second production line to be functional? Well, I have to come back to you on that, but it's more than 12 months away. Okay. Also just to add, that's also the reason why we are keeping production in-house, because it is cost- efficient and very good margin-wise to keep it inside. We can produce large volumes in our current facility. It's also a way for us to protect our IPR. Yeah. I fully agree on that. One more question on the FDA approval. To kind of gauge it a bit, have you received some questions that you could answer? I think that is always helpful to see a bit how much they are working on your application, then if you can expect it in a normal timeline already in May, or if it really becomes a bit later. Yeah. Do you see them to be active? Do you receive some smaller questions that they can answer? Yes. They've been very active initially. We got some questions, which we were pretty quick to return because it was not that they expanded into any new areas. They just wanted to drill down into more detail into the areas that we already submitted. That was pretty straightforward for us to come back to that. They're now doing their review on their end. All right. When did you get the last question, if I may ask? That was pretty shortly after they announced that they had restarted the assessment, the review. Okay. Thank you. They communicated that now we will be doing a review on our side for quite some time. We don't expect them to come back yet. It's in line with the feedback they have given us. Okay. Thank you. It shows that they're active. Yeah. One last question. I'm not sure if it was covered by the first analyst asking questions, but from the sales that you reported now, can you see in which indications the pharma companies are trying to use DiviTum, and is it in other indications that you are aiming at right now? Yeah. It is a mixture. Sometimes we have very little insight. Sometimes we have actually been entered an agreement, which is more full insight. We have in between where we, like the Pfizer results that were published, presented after completion of the trial. Yeah, it is a mixture. It is both within breast cancer for new drugs, and it is also outside breast cancer for new drugs or existing drugs to expand. Do you see a potential then also for you to go after these indications? Yeah. I think it's a very attractive model if you can do that in partnership with pharma. Yes. Okay With the regulatory process now moving forward, plus the experience that we have in Henrik and the customers that we have, we have opportunities that we, of course, need to explore. Okay. Thank you very much. That was all from me. Thank you, Dan. Thank you. We have no further questions. I will hand back to the speakers for any further and final remarks. Well, thank you very much for all the good questions and the interest for our interim report. Bye-bye from Anders and Cecilia. This now concludes our presentation. Thank you all for attending. You may now disconnect your lines.