Thank you very much, and hello everyone. Just thought directly move to the second slide. My name is Anders Rylander, and together with me, I have Cecilia Driving. Hello, everyone. Let's move to the agenda slide number three. Today we will talk about first a short introduction, what Biovica is and what we do. We'll go through the Q4 highlights. Cecilia will talk about the financials, and then at the end, we'll have time for a question and answer session. Next slide. Just a few words about Biovica, what we do. Biovica develops and commercializes blood-based biomarker assays to improve monitoring of modern cancer therapies. The way we do that is through our product, DiviTum, which is a biomarker assay that measures an enzyme, which is closely related to cell proliferation. The product has been part of several clinical trials where we have demonstrated the capabilities and the value of the product. The focus for us is to use it within metastatic breast cancer in order to monitor the outcome of the treatment during metastatic breast cancer phase. Sorry. This is to contribute to more informed decisions for physicians that will lead to best possible treatment outcome for cancer patients. Both patients and healthcare providers benefit from more effective use of resources and more effective cancer monitoring. If we move to the next slide, I'll talk just a little bit about the technology and how it works. As I said, we're measuring an enzyme called thymidine kinase, which is present in the bloodstream. We can, with our sensitive biomarker assay, pick it up and measure it. It's been shown in several clinical trials that this enzyme correlates very closely to the cell proliferation rate and also the aggressiveness of the cancer disease. This makes sense as cancer, of course, is defined as uncontrolled cell proliferation. With DiviTum, we measure proliferation that will eventually result in increased tumor volume. Currently, cancer treatment are being monitored with imaging as the standard procedure. With imaging, you measure the change in tumor volume, and that requires a couple of months to be able to follow up with the result. With DiviTum, we've shown that already after two weeks into treatment, we can see significant changes in patients that responds to the therapy. We can, with DiviTum, offer a quicker and more efficient follow-up assay. Very simple to take a blood sample from the patient. That's the high level about what the product does. The product is also implemented on a standard platform, which makes it easy to adopt for the different clinical labs around the world. If we move to the next slide, we have a summary of the most important events during the fourth quarter. It says third, but it's, of course, the fourth quarter that ended in April for Biovica. First of all, when it comes to clinical results within breast cancer, we did, in a collaboration with Karolinska University Hospital, a clinical trial that was performed several years ago within locally advanced breast cancer that now was published in the ESMO Open journal. This is important for us for several reasons. We would like to expand into locally advanced breast cancer from the metastatic area where we have the most of our documentation. It's also important for us to show that we correlate well to the well-established KI67 biomarker, which is based on tissue-based and require a biopsy. Of course, that we can provide similar information from a blood-based assay is a great advantage for patients and the treating physician, of course. That's an important outcome of that clinical trial. Another important thing is health economics and being able to get into the U.S. reimbursement system. In order to take the first step in that process, we've developed a budget impact model, which was presented at a conference in May this year, health economic conference. The conclusion from that model is that for every dollar spent on DiviTum, you'll get $3 back in savings. That's basically within the cost of treatments. The model is based on our clinical results so far, and also other assumptions regarding costs for treatments and diagnostics being used currently. This is important for our reimbursement process and our discussions with payers that we have initiated, and this will also result in a publication going forward. Another important thing is to have a strong team in order to execute our business plan. This quarter, we have strengthened the team both within the commercial area with Helle Fisker and the regulatory area with Joakim Arwidson. After the end of quarter, we presented results outside the breast cancer area, also in collaboration with Karolinska. This was within the metastatic melanoma area, where patients were being treated with immunotherapies. The results were also very interesting and promising. We were both prognostic and predictive before start of treatment. That opens up an opportunity, which we'll pursue further to widen the use outside of breast cancer and both within metastatic melanoma and we'll further look into the use to monitor treatments within immunotherapies. That was a short summary of the highlights. If we move on to the next slide, which is a summary of the FDA process that we are currently in. This is important for us since the U.S. market is our key market, which is, first of all, we're looking to launch the product. To be able to do so, it requires regulatory clearance. In this case, it's called 510 by the FDA, and that clearance would allow us to market the product on the U.S. market. We made our submission already in September last year, and we passed the first two milestones during autumn of 2020. Before the process was halted, and that was due to the pandemic situation as the FDA reallocated their resources to COVID test processes. The pause was prolonged, but we were lucky to be one of the few applications that was restarted, and this happened already in late January this year. Since then, we've been in what they call substantive review phase and been interacting with FDA. The process has been a lot slower than normal. For several months, we waited for a response from the FDA, but it has been restarted, and we are now in a good dialogue with the FDA, which is very promising. The milestone that we have set out to get clearance during the third quarter this year is what we still are working towards. That's a short summary about the FDA process. If we move on to the next slide. It's another area which is really important to us, and that's the laboratory partnerships. As we're looking to launch both in U.S. and Europe, we are in discussions with potential partners on both these markets. The reason for this is that we offer a kit, a test, but of course, we need partners that can perform the analysis as a service to the customers. We also are looking to make agreements with lab partners that have a sales force so it can be complementary to the sales force that we're working to set up in order to target the customers. We're working here in two steps. Before we get the regulatory clearance, discussing and will soon come to agreement that makes the test available for testing within research use only, which we are allowed to do already before clearance. Then, as soon as possible after clearance, we will move into a commercial agreement that offers the product as a service for clinical use on these markets. This way, by doing so, we can cut the time because there's a lot of activities that can be performed already before clearance, for instance, the validation process and so on. That's a short update about the lab situation. If we move on to the next slide, we have a slide about our commercial roadmap and the market potential within these different areas. If we start at the top, the focus area now is to launch the product on the U.S. market, which we expect to do later this autumn after appearance at ESMO. The first phase is to meet the first milestone we've set out, that we should be able to realize 15% of the market potential three years after launch of product. That will require hard work in order to get into the reimbursement system and expand coverage of reimbursement. A good way of doing that is through guidelines, which also we're working to get inclusion into, widen our commercial partnerships, and building our sales force in order to reach out to the customers. In this setting, we have a great foundation to build on with the strong key opinion leader network that we have established from the many clinical collaborations we've done with this area. Long term, we believe that we can realize 50% of the market potential. As you see to the right, for the metastatic breast cancer area on the market, U.S., selected markets in Europe, that is the five largest countries plus Nordics and Japan, we believe the market potential is around $400 million-$700 million per year. That's based from extensive market research we've done, where we have interviewed payers for feedback about the value and the pricing, oncologists, and also combined with the number of patients living with the disease. The next area to expand into is the locally advanced breast cancer area, where we can reuse a lot of the channels that we established within the breast opinion leader network and so forth. It just requires regulatory expansion in order to widen the use within the locally advanced area. Of course, clinical data to support the value of the product. We already are active within that area, and we have some ongoing trials in the area to build the evidence needed. The locally advanced area will extend the market potential further within the breast cancer area with 30%-40%. We already are looking to expand outside of the breast cancer area where we have done some initial clinical trials, proof of concept, as we call it. The metastatic melanoma is a very good example. We also have proof of concept data within the lung cancer area. The third area we are looking into target is metastatic prostate cancer. Those three together will further add the market potential with $1 billion-$1.5 billion. The last area we're looking into, and we are in an early phase, where we have collaborations with pharma. They are buying our product currently and using it in the development of new products. The next natural step is to try to move into to benefit, to build on that collaborations and do co-development projects, so-called companion diagnostics, in order to complement new cancer therapies with complementary diagnostics. This is the commercial roadmap long term, and the initial focus now is to launch the product within the U.S. market. If we move into the next slide, we will move into the financials, and Cecilia will guide us through that. Yes, I will. Thank you, Anders. We start with the sales numbers. The fourth quarter sales has been SEK 318,000, and they are derived from two new customers. It is both encouraging and satisfying that we are adding new pharmaceutical companies as customers, and they are using the DiviTum TKa for developing new promising cancer drugs. We look forward to work with them going forward as well. During the third quarter, we received two major orders and made the first delivery can be reported on those and on the last time. We haven't delivered anything more of these orders yet, so they still remain having to deliver when the customers need more kits for their trial, because this is Research Use Only orders. As you know, we focus our efforts on taking DiviTum TKa to the clinical market and expect to see more continuous sales after launch. Now we're going over to the cash balance on the right-hand side of this slide. The closing amount was SEK 145 million at the end of the year, and we are well capitalized ahead of commercialization in the U.S. and Europe. Our run rate now is about SEK 3 million for the last 12-month period, and going forward, this will increase when we invest in the launch activities. 3 million per month? Yes, per month. Cash assets are sufficient for more than two years of operations without factoring in the expected increase in sales. As you know, the higher level expense compared to last year is attributable to the DiviTum projects associated with the preparation for commercialization. Also the organization has been growing, and we are now 20 employees, compared to 17 last year. This will continue growing a little bit. The increase is in line what we have planned for. I'm handing over to you, Anders. Thank you very much. Just to sum it up before moving on to the Q&A. The next slide, the summary slide. We have a DiviTum product that addresses an unmet need within this area for more personalized treatment within metastatic cancer and specifically within the monitoring area. The product has been part of several scientific collaborations with some of the world leading key opinion leaders, so we have a strong foundation for our commercialization process. That's what we are in the middle of, so the upcoming milestones are much related to that. It's 510(k) clearance and launch within the third quarter, which of course, launch of product, means that we need to have a signed agreement with a lab partner that can offer the product as a service. By end of year, we are aiming to get our first reimbursement on the U.S. market. Also, before end of year, we are looking to launch within the first country of the Europe and Nordic areas. That will also need a commercial contract and a partner that can offer a service plus regulatory approval on the Nordic and CE marking basically in Europe. With that, we have a very exciting 2021 in front of us. With that, I'm opening up for questions. Thank you. Ladies and gentlemen, if you do wish to ask a question, press zero, one on your telephone keypad now. That is zero, one to register for a question. We have a question from the line of Rickard Anderkrans from ABG Sundal Collier. Please go ahead. Good morning, and thank you for taking my questions. Could you please outline in a little more detail, the steps that are left from achieving a 510(k) clearance to the first order being placed and shipped, so to speak, by a treating physician in the U.S.? what we need to do, of course first, 510(k) clearance, and that's not enough because we need to have a service agreement with a lab partner, which we together can offer to the oncologists, which is making the decision to order the test in discussions with the patient. we also need in that comes with a logistics solution to get to the samples sent to the lab because we will start initially with a pretty centralized model. we have the advantage here that the timing, thymidine kinase allows for shipping of samples. Initially, we expect out-of-pocket sales, until we get into the reimbursement system. in order to get into the reimbursement system, we will, together with our lab partners, set up a capability to claim reimbursement and then negotiate with the payers to do so. We also need to create awareness of the product, so we're working with that as well, both with our key opinion leaders to be present on upcoming conferences. We also have initiated discussions with patient organizations. We just recently this week had our first patient advisory board in order to create the awareness of the product and also, of course, get the patient's feedback in so we can tailor our messaging going forward. Right. Perfect. Thank you very much, Anders. On the partnership side, you seem to indicate that you could have more than one agreement in discussion and several per region. How should we think in terms of the number of potential agreements in place in the U.S. and E.U. in the next 12 to 18 months, what's possible and yeah? No, I think initially, we'll see with getting one agreement is important, because we can serve centrally because you can ship samples. Over time, we will add partners. Initially, you can expect during 2021, one agreement initially. On the U.S. market, and same thing on the European market, and then we will widen from that. We won't have exclusive agreement initially. That's not our plan. Perfect. We'll have multiple partners. Yeah. Sure. How short after potential clearance could you have a partner in place? Hypothetically. I don't know. We want to, of course, minimize the time. That's why we're already now initiating or in the discussions with partners to be able to initiate validation before clearance so we can cut time. It's more a commercial discussion after that. I can't give you a number because we're dependent on an external party, but we are working to minimize that so we can do it as soon as possible after clearance. Sure. Just a quick one on the PROMIX study. How should we think about the findings in that study, given that measuring thymidine kinase is typically not compatible with the use of chemotherapy? Just so we understand the results there. No, that's good that you point that out. that's a trial that we initiated actually, a couple of years ago. since then, we are more focused towards endocrine therapies and CDK4/6 inhibitors, which is our focus area. I think the value is more towards the prognostic, that we can have a prognostic value also in the locally advanced setting. That's interesting. We already have other trials within that area, so that further confirms that. also that we could be a liquid alternative to KI67. That's also valuable to us within other settings. when it comes to the treatment regime, you're right, that's not our focus area, chemotherapy. we see the opportunity in locally advanced more that when, because we expect the CDK4/6 inhibitors to move into that area for hormone-positive patients. Perfect. Thank you. Just a final one. Do you have any examples of launches of ELISA-based biomarkers in oncology in recent years? I just thought that it could perhaps guide our thinking in terms of launch trajectory, et cetera, or should we just stick with Oncotype DX type trajectory? Yeah, I think you should because we're not exposing the platform to anyone else in the lab in that sense. We will offer it as an analysis service to the customer. With a lab that can perform this centrally, when you ship the samples, you're able to get up the volumes and have an efficient process and possibly automate the ELISA, which takes away the biggest disadvantage with ELISA, which is the manual process. There is the laboratories that you're speaking with. They have been, and they are currently integrating automation solutions for new ELISA test kits that are coming in, essentially, and it's a sort of standardized procedure for them. Yes. We've been discussing that as well. They have a different infrastructure per lab. Some, for instance, in Europe, it could be that they have an instrument that's possible to automate, which is only CE marked but not FDA cleared. In U.S., it could be a different situation. That's a discussion you have to take per partner. Sure. Perfect. That's all from me. Thank you very much for taking my questions. Have a good day. Thank you. Our next question comes from the line of Johan Unnerus from Redeye. Please go ahead. Thank you, Johan Unnerus. Thanks for taking my questions, a few remaining. On the FDA process, is it possible to be more specific where you are? Are you in the interactive review stage, or? We are in the substantive review. I don't know if they are already following there, because the interactive review is when you're in discussion with the where you don't stop the clock. In this case, the FDA themselves have paused for a couple of months before coming back and so on. It's a special process. We at least can tell you that much, that we have received in several rounds actually, questions. We responded, and now we get further questions that we are now working to respond to. We have a good dialogue. We think the questions that we get are reasonable. We understand the rationale. We're working with coming back with an answer to them. Yeah. That's why FDA is not following the normal processes with interactive review and additional information. Thanks, and we hope to the normal process. Thank you. That's helpful, and that's also a step towards my next question. These questions and the final clearance, will that involve some indication as to precision, and could this also have a bearing on how you calibrate the test and what sort of precision that could be described? Yeah. I'm not sure I understand, but yes, those discussions are ongoing. The FDA has both high and low, both very detailed, but also some more on the intended use, for instance. It's not changing the intended use, but it's just wordings. That will affect how you calculate the performance outcome and so on. That's why we will communicate data like that after we have a conclusion or agreement with the FDA clearance. I think the main message here is that we're really happy that the process is restarted, and we're in discussion with the FDA. We know what to come back with, and we feel confident that we can respond to their questions. Excellent. Just the clarification as to the other presentation and questions regarding non-exclusive partner in the lab market from the US side. Yeah. Should we understand it like that the most likely is that you will have this agreement with one partner in the lab market, and that will move on to the clinical in the next step with the same partner, and then thirdly, adding more? Yeah, that's correct. That's our ambition now. Because then we can start the validation already and get the collaboration going and cut the time to the commercial agreement when we offer this to customers for clinical use. we will already offer it to customers for research use initially. This is an area we've been struggling a bit due to the pandemic situation. The labs have shifted focus to a great deal due to the high demand of COVID testing. even labs that have their focus within oncology normally have been occupied doing COVID testing, and their business development work has been reduced. The good thing here is that we see an improvement as the pandemic situations are getting better, and that opens up the opportunity to move forward for us within this area. Excellent, thank you. A reminder, please, regarding how many prospective studies that are sort of ongoing and, even better, when we can expect some first results. Yeah. That's a good question. The first trial that has been completed, it's the PYTHIA trial. It's with the IBCSG, Big Against Breast Cancer network, a very strong, key opinion leader network in Europe. That was presented at the San Antonio Breast Cancer conference, and Dr. Luca Malorni presented that at our Capital Market Day as well. That is, as Luca at the Capital Market Day said, is about to be submitted to a scientific journal to be published, hopefully later this year. That's the first one. We have ongoing trials. One is the Johns Hopkins in the U.S., where the patients have been enrolled, and the trial is ongoing. You won't see the results this year, but later next year, you can expect the results from that trial. there's a third one that has been mentioned, that Luca Malorni, for instance, mentioned at the Capital Market Day, and that's the BioItaLEE trial, where we also have been involved. You haven't seen in our official documentation since we are not involved in actual work. We just sold the kits, basically. As Luca communicated, that trial is also about to be completed and will be presented on an upcoming conference pretty soon. Those are the three ones that have been mentioned. There's actually a fourth one which I forgot. It is CDK4/6 as well, that Luca also mentioned in his presentation. That one is also being started up. We are looking to initiate smaller, more targeted trials for reimbursement processes, but we haven't specified exactly which ones. Excellent. Which was presented by Amy Williams at the Capital Market Day also, how we're thinking within that area. Yeah. Thanks. Just one again, is that fourth trial, is that the Novartis trial? That's the BioltaLEE trial that was mentioned by me. I forgot the Syndeo trial, which we have in our own communication, because we are a collaborator in that as well. Excellent. I think just have a look. Yeah. Finally, advanced breast cancer, you've been clear lately that we'd probably request a modified label later on. Yeah. Could you give some indication on the time, let's say that we will have that 510 decision in Q3. Can you get the advanced breast cancer within a year, or is that too early? I think I need to be careful to commit to timelines here. I can talk about the process, though. The big effort now is to get the product cleared, 510 cleared, including both analytical and clinical validation. The clinical validation is specifically for the metastatic breast cancer area. In order to widen the use for locally advanced area, we can do a supplementary process. It's an easier process. It requires clinical data supporting the value within locally advanced breast cancer. That trial we haven't specified. I think we can build on the fact that we have cleared the product in that case, and we only do have to do a supplementary process. Excellent. Would you expect to be in a position where you can specify the timeline by end of this year? Yeah, we will need to come back with a timeline. I realize that around that as well. Excellent. Thank you very much. That's all for me. I remind you that if you want to ask a question, you will have to press zero, one, on your telephone keypad now. We have a question from the line of Dan Akschuti from Pareto Securities. Please go ahead. Thank you for taking my question. Just a brief follow-up on the FDA discussion. You mentioned that there are open questions that you're now preparing answers to. Can you shed some more light on what the exact questions those are, and if there are some concerns from the FDA? No. I don't want to get into details more than I've done, but I can say that it is around different parts of the entire application. It's around the performance part and the clinical validation, and it's more of a discussion. The feedback from the FDA, it's reasonable. It's about how you interpret different standards, how you interpret the clinical trial setting, and so on. It's always based in science and facts from the FDA. We think the feedback is reasonable, and also, we believe that we will be able to come to an agreement with the FDA. Sometimes it has been that the FDA understands more that we have to explain better, so they understand and accept. Sometimes it's been that FDA points out that we need to add some documentation in our application. It's a good discussion, and we feel that we can respond well to the FDA, their feedback. Okay. Thank you. Maybe just regarding timelines, when do you think will you respond to these open questions? We're working right now, and we have been doing so for about a month. The real worrying thing for us was during that period when the FDA kind of paused the process. We're actually very happy to get these questions and get back into the discussions because then the process is progressing. We've been working with this for a month, and we will continue to work a couple of weeks into the summer. Basically, in order to make that deadline by end of third quarter that we've set out. Okay. Thank you. Just one more question on the partnerships. Can we expect that the FDA approval will ignite a cascade of payer reimbursement agreements and on top of that then the partnerships, or can we even expect some signings prior FDA approval? We have had the ambition to do it prior, but I think it's realistic to do, like you said, that the FDA milestone is important in the commercial discussions and could ignite that as well. I agree, both within lab discussions, but also it's an important milestone also in the discussions with pharma partners and payers. Yeah, it's an important milestone in many ways for us. Okay, thank you very much and good luck with everything. Bye. Thank you. There are no further questions registered, so I hand back to the speakers for any closing remarks. Well, thank you very much for your attention and the questions, and we will get back to you on the next quarter report and the signing as well. Thank you very much.