Right. Hello, everyone, welcome to the Biovica Q2 Interim Report for the fiscal year of 2023. Today, I have my colleagues, Cecilia Driving, our EVP and CFO, and Warren Cresswell, president of Biovica Americas, with me, and together, we will present the highlights of the report. This is the agenda for the call. First of all, I'll make a very short Biovica introduction, as I assume that the people that are watching this call are familiar with the company. If you want more information, you can find that on our webpage with a lot of in-depth presentations. I'll go through the highlights, Cecilia will cover the financials, and Warren will give you an update about the US status and the launch, et cetera. At the end, we will have a summary and a Q&A session, and you can already now post your questions. If you wanna be anonymous, you can do that as well. You have to check a checkbox in the bottom. We will also have our research analysts, Dan Akschuti from Pareto Securities and possibly Johan Unnerus from Redeye, right into the call, asking questions. Just a short update of Biovica as a company. The company is founded by researchers at Uppsala University that in 2009, based on research performed at Uppsala University. We made our IPO in 2017 and are currently being traded at Nasdaq First North Premier. Headquarters are still in Uppsala. We have now expanded into U.S. with a headquarter and a lab in San Diego, which Warren will talk a little bit more about. This is, of course, since U.S. being our biggest and first market to launch the product for clinical use. In order to launch a product for clinical use, you need a regulatory approval. We have both CE marking for Europe. Since July this year, we also have a 510(k) clearance, which we announced in previous quarterly report. A few words about our product, DiviTum. DiviTum stands for dividing tumor, and that is also indicating what we can do with the product. From a simple blood sample, we can measure an enzyme called thymidine kinase, that correlates very well to the cell proliferation of cancer tumors. This has been shown in numerous clinical trials that has been published. To date, it's 24 published with DiviTum. Of course, cell proliferation is something that's essential in general, but very much so in case of cancer as cancer grows through uncontrolled cell proliferation. By measuring cell proliferation, we can provide important information, how aggressive the disease is, and also on the prognostic of disease development. A very important application that we also shown that we can do with DiviTum, which is also the application covered by our 510(k) clearance, is the ability to monitor patients being on cancer treatments, and especially so within the metastatic breast cancer area, our first application. This is because these therapies that we're monitoring should of course reduce cell proliferation rate in order to be effective. This is something that we've shown that we can provide feedback on very quickly, already two weeks into treatment. About three months ahead of the standard method being used today, which is image diagnostics. Image diagnostics requires that you take a snapshot of the volume before start a treatment and during treatment. By measuring cell proliferation, that essentially is what's gonna become a change in volume. We have a very easy-to-use tool, which is convenient for the patient, but also provides quicker feedback than the current method being used. This is, of course, important, most so for the patient, getting feedback, making sure that you get an effective treatment. If you're not getting an effective treatment, that you can do something about it, of course. There are many treatment options within metastatic breast cancer, specifically, but also, within metastatic cancer areas outside the breast cancer. This is really essential for the patient, first and foremost, but also for the healthcare providers and the payers paying the bill, as these treatments are often highly priced. In the breast cancer area, the average cost of treatments within hormone positive breast cancer, which is the area that our intended use covers, the price tag is more than $10,000 per patient a month. Of course, you wanna make sure that this money are well spent. Moving forward to our second quarter and the highlights. It started with us based on the 510(k) clearance that we got just before the start of this quarter. We announced that we would undertake a capital injection through a rights issue of a total of SEK 148 million. This is, of course, to finance the next step in our development of the company, which is entering the phase of clinical use and sales commercially to be able to provide this our product for the patients. Soon after that, we announced that we submitted our CLIA laboratory application in order to get CLIA certification for our lab in San Diego. Warren will update you later on where we stand in that process. We also updated the market about Anders Morén coming on as CFO for the company, starting January 1, 2023, replacing Cecilia Driving. After the end of the period, we have updated about that we have completed the capital injection. We also had an update on the CLIA lab, which Warren will cover, and we have presented additional results from on San Antonio Breast Cancer, which is the biggest breast cancer conference. We're moving on steadily when it comes to generate the evidence of the product. One thing that was mentioned in my report, which we haven't had any PR about, however, which I would like to highlight is that we are making progress also when it comes to our Research Use Only work and pharma collaborations, where we continue to make agreements with pharma and also starting new products where the product DiviTum will be used in clinical trials in combination of developing new cancer treatments with pharma. One other important milestone which Warren will co-cover is from the 1st of December that we have hired an excellent sales team with great experience. I'm looking forward to see what we can achieve together. Warren will cover that as well. With that said, I will hand it over to Cecilia, who will go through the financials before Warren will cover, our US status. Cecilia. Thank you, Anders. Now we're moving into the net sales. As you can see, this has been increasing, it increased since last year. As Anders already told, it has to do with research collaborations. We see an increased interest in DiviTum for this and have more and more collaborations, which we also reported on in our earlier presentations. The next coming years, you will see this even increase even more because we have so many more research collaborations ongoing and new questions every day. This really is, you can really see that it's this more and more important tool for the pharma to make new drugs. We return to next slide and go into the cash balance. The closing amount of cash was SEK 47 million at the end of the quarter, and we have finalized the rights issue and also have got in SEK 148 million that we raised before the issue costs. We also have told you earlier in the prospectus that this will last until June 2024. Also something that came earlier is the growing organization. As of the report, we have 27 employees. As you all heard, we have eight new in customer-facing team coming in from the first of December, which does both increase cost but also generate revenue going forward. I'm handing over to you, Warren, to talk about the US launch. Thank you. Thank you, Cecilia. Thank you, Anders. If you can advance the slide to my first slide, that'd be great. One more slide, please. There we go. Thank you. Over the last quarter, the U.S. has made significant progress developing our CLIA laboratory, executing pre-launch activities, hiring customer-facing teams, and this includes sales and market access, in addition to hiring expertise in both managed care, which focuses on reimbursement, along with revenue cycle expertise to focus on insurance claim submissions. Next slide, please. One too many. There we go. With respect to our CLIA laboratory, our highly experienced team finalized all state requirements and submitted our CLIA application to the California Department of Public Health. This was early October, I believe it was October 13th was the exact date. We were notified that the application has been reviewed, and the last part of the approval process, which is a site visit, has been requested early January 2023. We do believe that the California Department of Public Health has reverted back to their pre-COVID processes. When we started this process, we believe that the site inspection was actually post being provided the CLIA application. This did add just a very short additional time to the ability to get that CLIA license. We have been in contact with our field examiner from California Department of Public Health, and we have provided all necessary documents pre site visit. This was done immediately. Because our team is highly established and are experts at building CLIA labs, we anticipate this process to continue to be seamless. In fact, we do look forward to showcasing our laboratory to the state. It should be noted that the request for a site visit does not delay or impede any of our commercial activities. Just to repeat myself, there is no delay in what we're doing from the commercial side. We're also really happy to and very proud to report that prior to the end of this month, we'll start testing clinical research samples from our CLIA lab for our pharma partners and collaborators. We've also started receiving samples from both retrospective and prospective studies. Our prospective clinical trials, one of them is using our blood sample collection kit that was developed in our facility in the U.S. Expanding our ability to test clinical research samples in both the U.S. and the European market increases our capabilities to drive clinical research business. In parallel to being granted our CLIA certification, we're working on our College of American Pathologists, that's CAP accreditation, New York State and Washington State licenses, and also our ISO certification. It should be noted that once we do receive our CLIA certification, we will be able to immediately receive, test, and report patient samples. Next slide, please. We're also very excited to announce that on December first, we expanded our U.S. organization and hired a really highly experienced and skilled diagnostic and diagnostic commercial team. These team members have an average of greater than 20 years of experience, and all team members have experience in launching high-value novel products, developing new markets, engaging specialty physicians, contracting with institution, and developing KOL relationships, along with driving the reimbursement process. Our new team members joined the organization with a significant number of key relationships. We've already started to leverage those relationships and get in contact with those folks we've known in the past. This is really beneficial to our launch efforts. Our strategy also includes hiring leaders that we can build teams around. All of the individuals we've hired are highly experienced, and as we scale the organization, we will build teams around these folks. Next slide, please. We've implemented a sophisticated physician targeting methodology that ensures that our customer-facing team is focusing initial sales efforts on medical oncologists that have a high population of women that are hormone receptor-positive, HER2-negative, post-menopausal with metastatic breast cancer, and are being treated with endocrine therapy and a CDK4/6 inhibitor, which is a first-line therapy option in the U.S. Our targeting methodology also gives us detailed usage in institutions as well. We do know what volume of patients go through each institution. When we overlay this information along with key opinion leader relationships with institutions, notable treating centers, cancer treating centers, geographic locations, we can initially engage a target of 750 medical oncologists with our current team, which makes up 50% of the total available market. This approach ensures that we're focusing our efforts on the target medical oncologists and the institutions that drive sales force efficiency through this process. In parallel, our market access team is focusing on institutions that are affiliated with these targeted medical oncologists, in an effort to establish DiviTum access to physicians and patients, in these institutions, and as well will drive this client bill contract process also. All these activities, including our engagement with key opinion leaders, regional thought leaders, and medical oncologists, are all aligned with our launch strategy. We will educate healthcare practitioners on DiviTum, we will review the order and sample acquisition process, and we will ensure that physicians and the back office staff understand our financial assistance program. Our market access team will engage targeted institutions such as NCI, NCCN, notable cancer centers, academic institutions, and IDNs to develop access and work towards contracting. Next slide, please. Our U.S. reimbursement strategy is being executed by Scot Nelson, who's head of our managed care in the U.S., and Scott is one of the recent hires by us. Scott is actively building our reimbursement clinical argument and will engage Medicare in the coming months. Our CPT code strategy will be centered on pursuing a proprietary laboratory code, and that's also known as a PLA code that many of you have heard. There are four separate time periods throughout the year that a PLA code can be applied for. At launch of DiviTum, we will immediately submit our PLA application code for review, and we will open up discussions during that point in time. During this process, we will pursue a crosswalk methodology, as we have identified similar technologies that align with our desired average selling price. The output of the PLA process is to have a unique code number that is specific to DiviTum, being run in our lab in San Diego. From a private insurance perspective, we'll engage PPO networks, to provide access for members of employer-sponsored lives and provide negotiated terms for claims processing by third-party administrators. We'll also engage commercial payers in states that mandate coverage for biomarkers in advanced cancer where formal policy engagement is not required. Lastly, we'll also engage commercial payers where we believe that we have a favorable medical policy coverage. We will have heavy engagement with society treatment guidelines such as NCCN and ASCO with the ambition of gaining guideline inclusion, and we will of course do this by leveraging Medicare coverage and clinical utility data to accomplish this. Send back to you, Anders. Thank you, Warren. Appreciate that. Just to summarize, where we stand before moving into the Q&A session. We have a very product with great potential for both patients and healthcare providers, which can, from a simple blood sample, measure cell proliferation, something that's essential within cancer, and thereby provide very important information. The product addresses an important currently unmet clinical need, and we have strong support from key opinion leaders, some of the world leading, especially within the breast cancer area. Together with them, we have published results from 24 to be specific, clinical collaboration trials, with which 13 are within breast cancer, creating a very strong evidence of the value of the product, especially within breast cancer also that has this led to our 510(k) clearance, and we expect this to be, or this will be a key asset when entering the reimbursement discussions and to generate demand within this key with our customer, as the oncologists are being the key customer group. The market potential for our product is valued at more than $2 billion yearly within the area of metastatic cancer. That's for our key indications on our key markets. The metastatic breast cancer area is about 25% of that market potential. That's the area that we now have the 510(k) clearance for. We also are launching the product for clinical use on the single biggest market, the U.S. market. Our planned launch for Q4, 2024, 2022. As we stand, we are now moving into 2023 for the CLIA lab certification. We can still do the commercial activities. Focus in 2023, it will be on the PLA code and making agreements with hospitals. During 2024, you can expect the Medicare coverage and during beginning of 2026, 3 years after the actual launch, we'll launch beginning of 2023, you can expect 50% of the market potential for U.S. that has been identified for breast cancer. When it comes to Europe, we are also looking to launch here, in on selected markets in Europe the first half of 2023. We'll come back to that soon. Now I'm entering into the Q&A session, and the first one I'd like to put in line is Dan Akschuti from Pareto Securities. Dan, if you could unmute yourself and please. Thank you very much for having me, and thank you for giving this update and us the opportunity to ask questions. Sorry for my voice. I have a bit of a cold. Yeah, congrats again on the progress. It's really exciting to follow your struggles through the pandemic and still getting to the approval. Congrats on that. The question on the launch and when we can expect the 15% that you mentioned in terms of part of the market is, you mentioned three years after launch, but how can we also, if you maybe combine that with the 750 oncologists that Warren mentioned, that will be addressed. They are supposedly making up 50% of the market, so that would then exceed the 15%, of course. How do you think about that also timeline-wise and like with the staff that you now hired, are you able to address those oncologists within a year or have them meet your sales staff, et cetera Thank you, Dan. That was a couple of good questions baked into one. Maybe Warren, if you can elaborate a little bit. First of all, I think Dan touches upon a really important question which we have presented previously. How do we look at the different segments of the market and how big are respective segment and how are we intended to address them? Because that's a key sub-question to how do you get to the 15%. Please, Warren, elaborate a little bit on that. Absolutely, thanks for the question, Dan, I appreciate it. With respect to getting kind of that 15%, you know, it does take time to get in front of oncologists. It does take a bit of time as well to be able to educate physicians on DiviTum thymidine kinase activity. You know, the real benefit that we have with our product and our total available market is that approximately 50% of the patients are Medicare patients, so they're covered by the government. With our reimbursement strategy, you know, the first step is really working with Medicare to be able to get this PLA code. With that PLA code, that provides us with coverage for essentially 50% of our market. you know, we would love to say we could achieve more than 15%, but there. You do have to go out and educate physicians on the clinical utility of the product. The sales force that we have right now, they will be able to manage those 750 medical oncologists. some of those medical oncologists will be easier to get access to. You know, there are always some doctors that are no call accounts, so it's difficult to be able to get access in. Some of those physicians as well, they really rely on the key opinion leaders and things of that nature. There is a process, you know, overall sales process here. I think we're situated very well to be able to achieve that 15%, based on the population, that our test serves, you know, 50% being Medicare. You know, part of our strategy being able to drive contracting with institutions, and this really eases the burden to order the product. Also from a financial perspective, it provides us with payment certainty as well. You know, really being able to use those two levers, we believe we can achieve 15%, by the end of year three. The private insurance side of things, that takes a little bit more time. You know, they're usually slower adopters, so they take a look at what Medicare is doing, and they take a look at society guidelines as well. You know, once we're able to get through Medicare and get on society guidelines, then we'll be able to work and bring in those larger payers as well. Hopefully I answered your question. Thank you very much. Maybe a follow-up to the last point you just mentioned. Regarding guidelines, you also mentioned the ASCO, for instance. That is, I guess, something that would come only after some use, or when would you expect that after two years or three years? You were at the last ASCO. Do you have any plans also for this ASCO? Yeah. That's a great question. We haven't given a prognosis about that, but we've said that much that we will aim for NCCN and ASCO. Those are the most prioritized guidelines for U.S. We will start interacting with these guideline committees, especially NCCN ordered it this year, and we expect to get guideline inclusion in a couple of years. That's the two, three-year interval that you're talking about. We haven't been more specific than that. To our advantage, our clinical data, we have our clinical data because the guideline committee will be looking at your clinical data, what has been published, and we'll start that discussion during 2023 as well in order to get guideline inclusion a couple of years later. When we have received the feedback from NCCN, during those discussions, we can be more specific. Okay, thank you. ASCO is a bit more difficult because they haven't the same structured process as NCCN. We believe also that NCCN has more impact than ASCO, although ASCO is important as well, of course. Okay. That's good to know. And, do you have any kind of support from the KOLs you had earlier, like Daniel Hayes, for instance, for these guideline discussions? Well, you could say not specifically that Dan Hayes, for the listeners, is a former ex-ASCO president. Of course, he acts and we have had advisory boards, et cetera, and we are meeting him frequently, so we can get some input. When it comes to guideline inclusion, it comes down to our data. Okay. Thank you ... we can get guidance, but it's the data that counts. That's the strength- And you- ... strength of ours, so yeah. Right. I agree. You have a very large amount of clinical data. One question on the target reimbursement amount that you mentioned. That has been a bit, I think, changing in the past. Is there any new guidance that you could share in terms of kind of a ballpark that you're aiming at? Maybe Warren, could you elaborate on that? I didn't hear the entire question. I heard it was about reimbursement and levels, wasn't it? Did you hear it, Warren? Yeah. Yeah, I heard. I think the question was do we have any new guidance on what we've said in the past in regards to probably average selling price or reimbursement and I can answer that. There's no new guidance. We still are aligned with what has been presented in the past in regards to that. Okay. Thank you for that. That was, I think, if I remember correctly, now around $500 per test, or... We've said that when we estimated our market potential, we have used because we're presenting an interval, we used an interval of $300-$500, and then we also have published health economic data based on an average selling price of $400, so in the middle of that interval. That's the assumption we're working with. Okay, thank you. I think I leave some time for the other questions. Yeah. Perfect. Thank you, Dan. Thank you. Thank you, Dan. Should we move on to Johan and Anders from Redeye? Johan? Thank you. Thank you for taking our questions, and congratulations as well. First question then, of course, it's, you made considerable progress, but there is a slippage than in a clear timeline due to this visit in January. You, you seem to have plenty to do anyway, but of course, it is a critical question. What is the level of risk for any further delay? It's, it's never 0, I suppose. Yes. You are right. We take our milestones seriously. For that reason, we would like to have been able to say that we had received that certification before end of year, just as we said in the past, like you pointed out. That is correct. The good thing is that since we have the 510(k) clearance, the team that we now have put in place can start meeting with oncologists, potential customers, academic centers and hospitals, payers, et cetera. That doesn't limit us. We can do that in parallel, generating demand, that when we get the certification, we're ready. We have demand and can start offering analysis to these customers. Yeah. Then if I... Of course, we would like to keep our milestone, and this, of course, slight change in process means that we will have the visit during January. Warren, maybe you can elaborate a little bit about the probability of us passing the this audit or visit and getting that certification during the first quarter of 2023 that we now state. Warren, please. Yep, absolutely. Thanks, Anders, and thanks for the question. Yeah, I think there's no doubt that the probability, we believe, is extremely high that we're going to be able to achieve the CLIA license, you know, soon after the site inspection. You know, the piece of information where we don't have control over the side of things is the state of California. You know, they work off of their timelines. They're very busy, and they're also coming out of this kind of COVID era where they're doing a lot of these site inspections and audits that they were not able to do previously, during COVID. I think we unfortunately got a little bit trapped in that. The state's been great to work with. The real benefit I think that we have on our side as well is the team that we have put together here in the U.S., they're experts at building CLIA labs, operating CLIA labs. Our medical director, he's got a lot of experience with this. He's also a CAP auditor, and same with our clinical laboratory scientist. She too is a CAP auditor. This is not the first time these individuals have done something like this. you know, from a, from a probability perspective, I give it a very high probability. I don't foresee there being any issues on our side. It's just timing from the state that we're managing. Thank you. That's helpful. In terms of the commercial activities and preparations that you are undertaking right now then, how should we measure the progress as we proceed into 2023? The of these three segments that you pointed to, it seems to be the contract part that could come first, and you may even have initiated some discussions. Warren, please. Yep ... elaborate- Absolutely. what we can share. Absolutely. Yep, our activities, you know, at the very beginning, it's probably a little bit difficult to measure, other than, like, we have put together call plans. With these call plans, we've separated out these 750 medical oncologists. Actually, our sales force is reaching out now to set up meetings and appointments and things of that nature to have a dialogue about DiviTum. Also with our market access folks, they're actually reaching out to institutions also to be able to set up those meetings. We're really targeting the physicians that are affiliated with those institutions, and we're really hitting it from both ends. We're doing our best to have those discussions now. You know, it... There is a sales process, you know, typically, you don't meet with a doctor in the very first time they order the test. You need to meet with them, you know, a few times or several times and educate them in the back office, and also put into place some logistics in regards to sample handling and things of that nature. That's what we're doing right now. Really, how we're measuring it internally is, you know, the number of calls, the access to medical oncologists and things of that nature. I think the real measurement will be once we're able to launch DiviTum and being able to see, you know, the volume of orders that come in versus what we forecasted. To go a step further then, with this dual approach, should we, in a typical process, would there be sort of a specific validation or test before formalizing a contract with a hospital or center, or would it be possible to have a contract early on? You can certainly have a contract prior, then there's demand. Typically, institutions like to be aware of what's going on or what's coming down the pipe so that they can be prepared so that you can get that contracting in motion. Of course, since we hired an extremely experienced team, these folks have relationships with many, many, many of these NCCN and NCCN cancer centers. In engaging those folks, because we have existing relationships, we can actually discuss that and start that process of getting products contracted, you know, pre-demand. If anything, it's really more of informing them so that when that demand starts, we can either have a contract, I'm not gonna say in place, but we've had some significant discussions so that we can contract, you know, soon after. I do want to note that you don't need a contract with an institution to receive samples from those institutions and test. Certainly, institutions do prefer to have contracts, and so do we in place so that we can secure pricing and all the terms and conditions that go along with testing samples. You move along 2023, you will enter a stage where you can sort of be public or show in presentations the level of contracts and activities. I can answer that. I see that you're nodding, Warren. That is correct, Johan. We will share. Of course, we will share revenues, et cetera. On top of that, we will share KPIs on so you can see also a little bit more how we're developing. When we are entering agreements with hospital, we will make sure that, if possible, we will also announce them because that's, of course, in our interest also to inform investors how we're progressing on that area because it's an important area for us. Also from the presentation earlier, we get the impression that you are already sort of serving pharma collaborations. Yeah from the U.S., your US lab. Is that correct? We will serve from the US lab. Yeah, the majority of the pharma collaborations we have are within U.S., so it makes no sense to ship samples across the Atlantic. We have now received orders that is incoming, which we intend to serve. Just currently, with the lab established, we can't. We haven't had any orders yet. But the lab, we can use for Research Use Only before we have the CLIA certification. Theoretically, it would be possible, yes. Okay. That would be interesting to. When you are in a status where you can sort of. When that is a fact, that would be interesting. Yeah ... to release as well. Because. Yeah. That's a good one. We could keep that in mind, yeah. Yeah. Interesting. Also you mentioned... Let's see how you framed it. Anyway, the... It was a few proportion of states that were in sort of relevant earlier on, of particular interest. Any states that you could exemplify, Warren? I'm not sure I understand. Are you talking about where we're gonna focus our efforts? Is that- Yeah. In the U.S. In the U.S. Which are the geographies in the U.S. that we could elaborate a little bit on. There is different- Yeah. Yeah. You go ahead, go ahead. Well, I was just gonna say, yeah, absolutely. You know, typically, most of the population in the U.S. are on coasts, so, you know, where we're gonna have obviously a heavy, a heavy effort is along the coast and also where the NCI and NCCN centers are. That's really where we'll spend most of our time. It's very efficient if you spend less time, you know, behind a windshield or on an airplane flying people around. Most likely it'll be up the coast. There are two states that we have to file for a license prior to being able to receive samples in, but that does not limit our activities in building demand for the product. One of those states is New York State, one's Washington State, which we're working on those licenses today, the application anyways. There's obviously a high population in New York, so we will absolutely focus on that. It's, it's really dependent upon, you know, population density in addition to, you know, where KOLs are located, where those notable institutions are, if you have an IDN. Most of the time it's along the coasts. Yeah. Is it also that, for the private insurance market that some states are more of interest? Yeah, absolutely. Absolutely. Actually part of the team that we hired in, For instance, a gentleman by the name of Tim Ramirez, he runs our revenue cycle business. He's got 25 years plus of experience. What private industry does is when they get paid by an insurance company, you know that you generate data off this, and you understand which insurance plans cover which areas, and it's usually state by state, and you understand which insurance plans have a greater level of coverage and a lesser area of coverage. This all builds into our strategy in regards to even who do we target from a client bill perspective versus a private insurance perspective versus which state we focus on. Yes, absolutely, that's very, very meaningful. Excellent. Finally, two questions. The first regarding these pharma collaborations that has been expanded apparently in some ways already visible in your sales, results. Not that we would ask you for a specific, guide for this level, but what level of activity should we expect during 2023? Yeah, I can answer that. Yeah. Yeah, that's a great question. The challenge within this area is that we have CDAs, because it's not public products on the market yet. We can give away some general information, and some of the customers has actually published data with our assay, so we can talk about those. The ones that has published data with our assay is, first of all, Pfizer, who did that already in 2018. Novartis, who recently published a BioItaLEE trial. Carrick Therapeutics, who published data or presented data at the San Antonio last year. Those are examples. All these clinical collaborations are within the breast cancer area and the CDK area. Not all are CDK4/6. There are new second generation of CDK inhibitors coming out, some of those are among our customers that are developing new version of CDK inhibitors. Carrick Therapeutics is a great example of that. Did I give some guidance, Johan, on what type of companies? Our core has been within this area of monitoring and CDK4/6 and cell cycle inhibitor targeted therapies. That's our sweet spot where the data that we have presented has generated interest from these partners/customers. We have not had like in U.S. now, we're investing in a strong sales force. We have had limited resources. It's more the result of the clinical data that we have presented that has generated this demand. We expect to do further develop this. We have already signed several projects that we know that we will carry out that will generate revenues. We expect the volumes to increase within this area going forward. If we can see significant demand with significant changes, we'll of course announce that. Such an example would be if we're able to reach our objective to enter a co-development agreement with pharma. If we have that kind of partnership project, we will get significant revenues from such a project. That's, you could say that's our ambition. Also this ongoing collaboration pays for that sales effort going forward, you'd say. Of course, in such a scenario, we would definitely communicate that. I think that maybe could answer, give you some guidance and give you some feelings what you can expect within this area. Excellent. Much appreciated. What about prospect for further publications of studies during 2023? Anything that could emerge? Yeah. In general, it's quite easy to forecast what is gonna come if you look at what's been presented on the processes normally that we present data at conferences that then later on becomes published. The recent presentations on conferences you can expect to see in full-length articles. Yeah. I don't want to forego exactly because it's a little bit out of our control, and it's our partners who is normally driving the process because we are contributing with the kits, and then there's a partner driving the process of publication. Therefore, I'm a bit reluctant to speak up about what our partners have submitted or not because I'm not sure that I'm allowed to do that. You can go back and see what has been presented, and then you can see what you can expect to be published. Yes. Also the US team has expanded, of course, as it should do. What should we expect in terms of operational cost run rate as we approach Q3 and Q4 2023? We just, you just given some guidance in that in the prospectus that we just published. Yeah. or just published. We published in October when the capital injection was announced. We also gave guidance that with this capital injection you can expect our to be financed to June 2024, and if you do the math yourself, we'll have a burn rate of slightly over SEK 100 million per year going forward, which is, yeah, including the expansion of the organization. Excellent. Finally, I saw in the presentation material you refer to development of DiviTum. I don't know if the framing it could be read as a new version. It could also be read, I suppose, as new applications for the existing platforms. How should we read that? I'm not sure what you're referring to, but in general, we have said that we are currently working within the metastatic breast cancer area, specifically with hormone receptor-positive area, which is the largest within metastatic breast cancer and also breast cancer in general. We have identified areas that we would like to expand, being natural steps going to wider usage of the product. One is moving into the so-called locally advanced or where you do neoadjuvant treatments, which means that you pretreat, and then you do surgery. During that pretreatment phase, you also have a demand for monitoring of the effects. This becomes especially interesting as the treatments available within metastatic breast cancer moves into the more local settings. They have been approved, and that's a trend we see, and we believe we can benefit on that trend, creating demand for our product also in those earlier phases. Outside of the breast cancer area, we have identified three very exciting areas that we are looking to expand into. One is the metastatic malignant melanoma, and we have published data together with Karolinska, and we are looking to expand our clinical evidence with that area as well. The reason why we find it so interesting is because these patients are being treated by immunotherapies or checkpoint inhibitors, and that's also what our data shows, that we have the potential to meet the unmet clinical need that exists with our product, just like we have within breast cancer. It's the same challenges. Great treatments but also with severe side effects and also very expensive. It's really, really important to get that feedback whether the treatment is effective or not. Outside of that area, these checkpoint inhibitors are also used outside of metastatic melanoma field, but that's where they first gained a kind of foothold, and they've expanded outside that field. Other areas that we look into that we believe are interesting is non-small cell lung cancer and castrate-resistant prostate cancer and working to establish clinical evidence within that areas as well. Excellent. Thank you. That's how I think the reference in the presentation or the report was that, in conjunction to the increased R&D expenses, and that was. Okay. Okay. ...the reason for the question. This is what you're looking into anyway. All right. Thank you. Very good. Thank you. Thank you, Johan. We have two additional questions. I'll just publish the 1st one. Thank you for your patience waiting so long to get this answer. This one is, can you comment on how many tests in metastatic breast cancer that are performed per year by the hospitals you target commercially, commercial agreements with in 2023? That's a very specific question. I don't know if you can. In general, we understand that everyone is interested in more detailed forecasts. We will also detail our forecasts going forward as we are being more mature on the market, so to speak. I guess that's more of a general answer. All right. Moving forward to the next one. All right. I did the wrong order here. I published the wrong one. I published another interesting question, which is actually three questions. Have you received a certificate of registration? Yes, we have, and it should be on our website. Will the site visit in January be a condition for issuing certificate of accreditation or actually certification, to be specific? Yes, it is, that's the change in the process. Initially, the authority said that we'll do that visit, site visit after certification. The process has been changed around, they will do the site visit first and then the certification. We believe it's due to going back to pre-COVID routines, but we haven't had that confirmed yet. That's we believe, and that's the reason for this change in process. As Warren said, the good thing is... It's always not good to communicate the delay in milestone. In this case, the good thing is that we can work in parallel generating demand. When we are done that, we believe we will have that certification in place. I think, if you could elaborate a little bit more on the CLIA process, I think Warren just did that previously, so hopefully we, you know, already answered that question. All right. Thank you very much. Appreciate you taking your time, asking question, listening in to this presentation. This is the new format we are looking to use going forward. Hope it also is a good format that you appreciate. Thank you for- Sorry. Yeah. There was a question from outside. Okay. Yeah. It says, "Any regrets during the last two years?" Something if you could- Okay. So- You would do it in a different way. All right. Yeah, that's a fair question. It is never that way that you get everything right, you don't have any regrets. It doesn't work that way. I think if you can get the majority of your decision rights, and especially the key strategic and important ones, I think, that's what you should aim for, and it's a, it's a reasonable expectation to put on yourself. I think if you assess yourself, doing that, I think we have been able to get the majority of those strategic decisions right, and I'm very happy and thankful for that. Some of those include, the establishment of the CLIA lab, or it's not certified yet, but I expect it soon to be. That's a strategic direction that we've taken. I strongly believe in that. Another one is the investments we've done in the U.S. organization. I'm super excited to see the team that we have now in place, and I'm super excited to see what we can achieve. We got that right, I think. I also think, seeing the feedback from key opinion leader oncologists, seeing our results, presenting our results on conferences is also something that I appreciate, and I think, we got it really right. If you look at the big picture, we got a lot of things right. I haven't yet mentioned the 510(k). I think we had a maximum outcome of the 510(k) process when it comes to the intended use, et cetera. Of course, I'm also, see if I can find the right word, saddened maybe, about, the value development of the company. I think we have come so much further, now a year later, when we have lost a very big portion of our share price or, and market cap. When you are developing a company, you are of course, working with the things that you can affect, and then the, external parameters also play a big role. In this fact, it's played a really, really big role, with, two big factors, the pandemic situation and the war in Europe, which is sad in many ways, not only from a financial perspective. We have been hurt by those factors. I have asked myself, could we have done differently? A lot of times. So far, I haven't been able to figure it out, because, we were dependent on the 510(k) process, to continue that milestone that was pushed forward by the pandemic. Yeah, long answer to a great question. As you can hear, I've thought through this many times. All right. Very last question, where do you see the company in two and five years from now? All right. Within two years, I think there will be a couple of milestones which we talked about, that we've checked. The one that we've established ourselves on the U.S. market and have been able to achieve that Medicare coverage, which means that we have the majority of our market addressed in the U.S., our most important market. In Europe, we have launched the product and have sales in, on several markets using partners that we are currently speaking with. Outside these two areas, I believe that we have pharma collaborations that resulted in at least one co-development project that we communicated. If you look a little bit further, I think we've expanded on all these areas. We have checked that goal in U.S. We have widened the penetration of the product in Europe. We have expanded in outside the breast cancer area. We have even more pharma projects going on. Right. Okay. Thank you very much. Thank you. Over and out. Bye-bye. Thank you. Bye-bye.