Welcome to the Q-linea Q2 report 2021. Today, I'm pleased to present CEO, Jonas Jarvius, and CFO, Anders Lundin. For the first part of this call, all participants will be in listen-only mode. Afterwards, there'll be a question and answer session. Speakers, please begin. Thank you very much for that. First of all, me and Anders are really happy to present for you our accomplishments during the Q2 of 2021. It's been a very exciting quarter as we've seen the presentation, and might have read in the report as well. I suggest we get going, and we take up the next slide, which is our disclaimer slide on slide number two, in case me or Anders will make any forward-looking statements. We move on to slide number three, where we have sort of the highlights of the quarter. You know, we as a company are developing disruptive solutions for faster infectious disease diagnostics, and the first product, as we could now announce during the quarter, is now CE marked. We'll talk more about that and the excellent performance we accomplished during that study. If we then look overall what we have done, apart from having the CE mark May 4th, 2021 for the first product targeting gram-negative bacteria in patients with bloodstream infections, we could also announce the start of our U.S. clinical study for the American market. We have also several commercial evaluations ongoing, and we are really receiving good and strong feedback from those early potential customers. We have also grown a little bit in the quarter and are now 150 employees and consultants at Q1 end. If we then look apart from our lead product, ASTar, now CE approved, we have also made some very good and excellent development, with our next product in development. That is a portable culturing technology that truly could enable saving additional more than 10 hours in a time to result for patients with sepsis. I'll also describe a little bit about the accomplishments we did there. If we move to slide number four, I would just like to put the 1st product into context. Sepsis or bloodstream infections is 1 of the most severe threats we have in our healthcare system. Sepsis is a syndrome that can occur if you have a bacterial infection somewhere in the body. Those bacteria can then leak out into the bloodstream, and under circumstances, our own immune system can start attacking our body and eventually shutting it down, leading to death. It's a big problem around the world. Every third second, a person will actually die from sepsis. In Europe and U.S., around half a million people will die every year. If you look at slide number five, where we put two of the biggest challenges we actually have for mankind, so to speak. We have sepsis to the left. As I said, the leading cause of death in our hospitals. Around one-third of every person that will die in a hospital will die from sepsis. Also septic patients, when they progress throughout the disease and move from sepsis to septic shock, they also move into the intensive care beds. Very expensive beds. We have few of these beds, as we have seen during the pandemic, and that's also one of the main driver that sepsis is the most costly condition to treat in the American healthcare system. Another problem, that's where Q-linea can come in, is that around 50% of all patients with sepsis are inappropriate treatment. That's the reason because you have to start treatment without actually knowing what bacteria is causing the condition, and also what antibiotic to use to treat the patient. Even worse, around 20% of these persons will die before you get the current diagnostic result. This is, of course, where Q-linea and our lead product, ASTar, can come in, and we hope things dramatically change the outcome for these patients. On the other side, if you look at to the right, you have antimicrobial resistance. This is, of course, a condition as soon as you start treating or using antibiotics, patients will receive a lot of drugs. Bacteria will start growing and develop resistance towards those antibiotics. It has been presented as the biggest threat to mankind. As you know, antibiotics has really changed the game in how we can make treatment for cancer, for surgery, and of course, to fight common infections. Here again, rapid diagnostic could dramatically reduce unnecessary prescription. For instance, it has been reported that for respiratory issues, around 65% of all treatments are unnecessary. It might be that the patient had respiratory disease caused by virus and not by a bacteria, and then, of course, you should not use antibiotics. We have sort of a very unique moment now to start acting upon this, because if we continue to use antibiotics and we don't have better diagnostic methods, it's sort of depicted that the death toll will rise to around 10 million people in the next 30 years. We really need to start act now, and we think that our product could be one piece of the puzzle in this very big, huge problem. We then move on to slide number six. This is really the highlights of ASTar, our first product. What I want to stress out is that we have developed ASTar together with our future customers that we are now, of course, approaching as a commercial company. We have really listened into what's the need for these customers today, and what do they highly appreciate when they look at these type of diagnostic methods. We have the four pillars, easy to use, fast, comprehensive, and accurate. I've just highlighted a couple of these areas within these four blocks. Full automation. What does that mean? I will come back to that on the next following slide. Also, of course, having a high throughput enables you to diagnose and run a lot of samples at the same time, meaning you can handle peak loads for daytime hospitals. Of course, you can also have a high sustained throughput on larger hospitals. If you look to the right, comprehensive. While if you're going to act upon the result, you need to have a comprehensive result, so you don't have to wait for a traditional test that can take additional 1 to 2 days before you can actually change treatment. Comprehensive panel is important. Last but not least, I would say, is a true MIC result, and the MIC result is the concentration that kill or inhibit bacterial growth. Today we have seen the rise of antimicrobial resistance. The value of the MIC has increased over the years, and we anticipate it to increase even further for the years to come. We think we have built a system that is future-proof, and also built to handle other indication apart from blood, such as urine or isolates. If you look at some of these areas and go into detail, what they actually will mean for the hospital and for the patient. We take a look at page number seven. This really covers the full automation. When you look at this lab, and I would say particular now under the pandemic, we have seen that you have a huge workload at the labs. You have very little time to spend on each sample to be analyzed. With full automation, it means that anyone in the lab can load a sample at any given time point, but it also means that the lab personnel can do more in less time. When we evaluated the system here in Uppsala University Hospital, that was one of the very strong feedback we received. They felt they can actually do much, much more with a system that's fully automated, and you also know that you will always have the same time to result with a system that you can simply load in less than 2 minutes, walk away, the result will be presented. If you have manual step, that means basically that you have to start a manual step, in many cases you might have to do something else in between before you come back to that particular sample. That could also provide, of course, longer, but also variable time to result depending on the sample and, of course, how much time you have at that given moment. We think that full automation is an absolute key for long-term success. Take a look at slide number eight. When we see rapid AST and the broad antimicrobial panel, that's also important. What you see in the middle of the image here, you can see the traditional diagnostic workflow for septic patients. Without going into detail, it's a multi-step, multi-day process. To start treatment day 1, empirically, meaning basically blind, because you are lacking diagnostics, you use all the knowledge you have as a physician to treat, but you still have to select 1 treatment to start with. You have to wait until day 3, day 4, depending on if you have the green circle where you actually know exactly what antibiotic to use to treat that patient with. As I mentioned early on in the talk, was around 20% of the people will have died at this point. Of course, time to result matters. ASTar with a full automation and of course, rapid AST, it means it can do that with little less effort from the lab, and you can also do it much, much faster. Here, the comprehensiveness of the panel comes in because if you have a broad panel, say around 20 antibiotics or larger, it really means that you don't have to wait for the identity of the bacteria. You can simply start as soon as you have a positive blood culture. If you don't have a broad panel, you typically will have to wait until you have the ID analysis and then select the appropriate panel if it's an E. coli or if it's staphylococci, for instance. Broad panel also could help you save time. If we then move into slide number nine, this is just one example where we think that you can see the value of a rapid AST. This example comes from the clinical study we did together with Uppsala University Hospital. This particular case was from elderly gentleman who had neurosurgery, he was then diagnosed with aspiration pneumonia. In the middle of the picture, you can see all the timestamps from the diagnostic workflow at the hospital. Day 1, he was put on cefotaxime. Then you can see that day 2 you had a positive blood culture, meaning that you can see presence of bacteria in the blood. Of course, at this time point, you could immediately start and load the sample into ASTar. ASTar then presented the results the same day and actually reported that it was resistant towards cefotaxime. At that time point, we were not CE approved. You cannot act upon that as you can do now. You had to wait until the next following day to get the verification of the traditional method, which actually verified, yes, this is a resistance towards cefotaxime. More importantly, ASTar provided results on 10 more antimicrobials compared to the standard practice, and it could also provide what antibiotic to use to treat this patient with. If you could have acted upon this already on day 2, we think this could have a dramatic outcome different for this particular patient. I think rapid AST is definitely here to stay, and we can see a big and growing need for these type of tests. We now look at page number 10, this becomes a little bit more complicated slide. I'll try to explain it from a high level. This is why is true MIC or MIC value is important, and MIC was again, the concentration that kill or inhibit bacteria. The reason is that if you can provide a MIC value, you can choose really the optimal antimicrobial amongst the various antimicrobials that the pathogen is susceptible to. If you look at the image in the middle, you can see two antibiotics. You have antibiotic X on the top and antibiotic Y on the bottom. You can also see the orange line, which indicates the breakpoint. The breakpoint are, of course, the guidelines as from EUCAST here in Europe, where you can see that below that breakpoint, below that concentration, it's called susceptible towards that specific antibiotic, or above it's called resistant. You can see the small arrow that indicates the MIC value. That's a value where you can't see bacteria growing in presence of the antibiotic. What is then the importance of the MIC value? If you look at antibiotics X, you can see you have three white concentrations between the MIC value and the breakpoint. In antibiotic Y, you have four concentrations, meaning that it's farther away from the breakpoint. Of course, you can have a more successful treatment with knowing a MIC value, which you can't simply choose if you have a method that only looks at S, I, and R categorizations or Susceptible, Intermediate, or Resistant. Here again, delivering a true MIC value could really select the optimal treatment for that particular patient's infection. It has a great value. Of course, when we see more antimicrobial resistance, this becomes more and more important. I have another example on slide 11. Here is a little bit different, but also knowing the MIC value could really guide the treatment for a better patient outcome. This example comes from Staphylococcus aureus, and according to the EUCAST guideline, it's called susceptible for vancomycin, that's one antibiotic, if the MIC value is equal to or less than two. The problem with vancomycin is that it's quite toxic to patients, so you don't want to treat the patient with a very high concentration of vancomycin because that can have severe side effects. If you look at the middle of the slide, you have one green box where you see a MRSA strain in X, which has a MIC value of 0.5 milligrams. Of course it's susceptible because it's less than two. On the other side, you have the MRSA strain Y in the pink bar. There you can see the MIC value is 2, also susceptible according to EUCAST. The problem here is that if you want to treat the MRSA strain with a MIC value of 2, you need to have a very high concentration to have an effective treatment. In this case, you would need around 800 mg/hr and liter. That is a very high concentration that is actually toxic for that particular patient. This is another example of just having an S, I, and R method. You could for sure treat the patient, but with severe risk of producing adverse side effects and toxicity in that patient. You might actually not use vancomycin instead, but use even a tougher drug. Here again, the MIC value can truly guide an optimal treatment for that particular patient. If you move on to slide number 12, this is just the overall possible benefits for providing faster results. These are three independent health economic studies that have all looked into what are the effects if you can provide the answer 24 hours faster than the current standard practice. From left to right, they have indicated a dramatic change in mortality. Of course, providing the correct treatment faster means much more possibility for the patient to survive. Also in the middle part, that's more towards antimicrobial resistance. If you can early on go away from a broad-spectrum treatment to a narrow-spectrum directed treatment, of course, you reduce the pressure for antimicrobial resistance to develop, and you reduce the pressure for superinfection, which is a huge problem in our hospitals. For the hospital to the furthest right, we can also see that this particular study indicated that if you are on the correct treatment faster, the patient can actually leave the intensive care bed, the expansive beds, the beds we have too few of in the hospitals, on average two days sooner. That, of course, is a huge cost saving for the hospital and also it frees up capacity in terms of care beds. As we have seen during the last year, this is something that's extremely important to have those beds available. ASTar could overall in general provide 24-40 hours fast diagnostics. We think that we are really looking forward to starting our own health economic studies to really look into how ASTar could play a role in the treatment outcome for these patients. If we then move to slide number 13, we then move into some of the key highlights for the Q2. Of course, the biggest one was the CE-IVD mark that we received from ASTar in May. We had very strong, excellent data. We'll show that on the next slide. We had broad coverage in our panel, and we got strong usability feedback. As I also mentioned, of course, we're also not just focusing on Europe. We want to go to the U.S. market as soon as possible, and we could start the clinical study for the U.S. market in June. We will perform a majority of the analysis in-house here in Q-linea in Sweden, and we are now in very late stage contracting with very reputable hospitals in the United States, which we look forward to announce in a not too distant future. Thermo Fisher Scientific is also preparing to ramp up and starting the reference testing, that is also something that's going to happen in the very near future. Of course, what we have also seen is we have now several sites currently participating in the commercial evaluation of ASTar, this is done together with Thermo Fisher Scientific. We're actually led by Thermo Fisher Scientific, we have received so far very positive feedback from those evaluations. As you could also see from the Q2 report, at this stage of launch, we don't plan to see positive margins really within the first year, that depends, of course, on strategic placements of instruments at the right customers, initial low volume on kits versus instruments at this stage. This business is really driven by consumables, we want to see that ramp up. That's why I think the full automation, the high throughput, has set ASTar in a very good spot to be able to accomplish that. If we look at slide number 14, these are the summary data from the CE study. If we focus on the left part of the slide, there are typically three major categories where you need to present stronger data compared to the guidelines. From top to bottom, we have what's called the essential agreement, and that is really that the system can provide the same MIC value as the reference. You can see what you need to be above for FDA and ISO. It's 90% or 89.9 in the U.S., and ASTar provided 94.7%. Very strong results on the MIC value. In the middle part, you see the categoric agreement. That's the SIR, because, of course, ASTar provides not only MIC value, but also SIR treatment guidelines. These can be used also by general practitioners, physicians, in a bit simpler type of diagnostics. Again, you need to be about 89.9% in the U.S. and 90% in Europe, we had 97.6% in the study. Super strong results. Last, you have to provide reproducible results, meaning that you give the same answer every single time. Here, requirements are a bit higher. It's 95% for both the U.S. and European market, ASTar presented 99.6% reproducibility. Very strong data in the study. If we then look to the right, of course, this was our first product launch, our first panel launch. Already today, we offer the broadest combination of antimicrobials and dilutions of all currently available AST solutions. Of course, we deliver true MIC results. On the small graph you see below to your right, here we compare the coverage of antimicrobials and dilutions with the two other companies that provide a fully automated solution on the market. Of course, ideally on this graph, Q-linea is the orange circle. You want to be as high up to the right as possible to have the broadest coverage. You can see that we already now by margin provide the broadest coverage. We are not satisfied. We really want to broaden the coverage even more, and we are still working with extending the capabilities of our system, to really be able to act upon 95% or above of all infections. I think that's a very good goal to strive against. If we now look at slide number 15, we have some follow-up on the Q2. Of course, we had a very successful direct share issue, with gross proceeds of SEK 301 million. This really enables us to strengthen the commercial activities, build production, ramp up activities faster, and of course support geographical expansions. We see together Thermo Fisher, a very promising market and a huge market for these type of products. Of course, we see ASTar to be a good product in that market. Also, as I mentioned in the beginning, we also had some very successful development of our portable culturing technology. We now have fully autonomous prototypes tested with excellent results. We are doing a European and U.S. market study that's ongoing to really fine-tune the concept. Of course, by having a portable culturing technology, it really means that you take the capabilities of culturing of the central lab, because that's where it happens today, and you move that out to the patients where you take these samples. Of course, what that means is you can have a much more streamlined workflow in the lab. You can save more than 10 hours for many blood cultures, because today that needs to be transported from the site of sampling to the central lab, and that can take a lot of time, 10 hours or even more. Of course, during that time today, nothing happens with the sample. With our technology, as soon as you load the portable culturing technology with the sample, you start incubating and reading. Of course, all the time that you have today wasted can now be used. To me and to us in Q-linea, it's very important because we could then provide equal and better care for everyone. It doesn't matter if you become sick outside the hospital or during nighttime, you can still have the same time to result with this technology. We really look forward to taking that to the next step of development. If we move on to slide number 16, we of course, need to comment on the corona pandemic. I see, as I hope you also see, we see a slow but steady move back to the normal life. We have seen a decrease in the COVID cases within the company, and we have seen, of course, more and more employees now being vaccinated. We have actually started during this quarter for the first time to deescalate some of the protective measurements within the company. Far, we have seen no major changes in timelines due to corona or COVID. Of course, as you can see, we see the Delta variants. There might be more variants coming up. The timeframe for the studies we plan can be affected. We still have to follow it carefully and see what happens. Far, I think it looks good. We could, of course, see a potential effect on the commercial activities, either within Q-linea or with our partner, Thermo Fisher Scientific. We still see that it's moving in the right direction, and we're very happy about that. Of course, we're most happy that more and more people are vaccinated and less likely to actually die from this virus. I think that is what should be most important to all of us. As we say, it's not over yet. We follow it carefully, and we try to do corrective mitigating actions when possible. Fingers crossed that vaccination will really ramp up throughout the world, and that they are effective through the new variants that we see. With that, I move to slide number 17, and that I will hand over to Anders Lundin, our CFO in the company. Please, Anders. Thank you, Jonas. I will in three slides go through the highlights of our income statement, balance sheet, and cash flow that were reported this morning in our Q2 report. Starting with the income statement for the Q2, we saw that during the Q2, the company carried out the first sales to Thermo Fisher of ASTar and consumables. We reached SEK 4.3 million here. As Jonas already mentioned, we are having a negative cost of goods sold of SEK 9.3 million, giving us a negative gross margin of SEK 5 million. Minus 117%. We had an operating result of minus SEK 68 million, which are higher than the same quarter last year, mainly due to increase in the personnel costs. We reported a loss after tax of SEK 67.9 million. Earnings per share before and after dilution were minus SEK 2.47, that is compared to the same quarter last year, SEK 2.37. If I move into slide 18. The balance sheet that we have by the end of the Q2, we have cash and cash equivalents of SEK 48 million, and the SEK 10 million, the comparison is by the end of the year, end of 2020. We have this direct issue, we got the liquidity. Sorry for that. We invested the liquidity in the short-term fixed interest funds, SEK 221 is the balance by the end of the quarter. We have also invested in enlisted bonds. The total of that is SEK 184, and we have also short part of the bonds of SEK 57.1. We have inventories of about SEK 22.6 million compared to the SEK 12.4 by the end of the year. That includes a write-off of SEK 2.8 million in the quarter. Going to my last slide on slide 19. Sorry. That is the cash flow statement for the Q2. We had the cash flow from operating activities was minus SEK 45 million, which was improvement with SEK 10 million from the same quarter last year. The decrease in the cash outflow, it's mainly due to the improvements in working capital, which is temporarily, you can say, we have increased our accounts payable and short-term liabilities. That's mainly invoices we will need to pay during the next quarter. We have some investing activities of SEK 203 million, which is the investments we are doing in the short-term interest funds and listed bonds. The financing activities in the quarter were SEK 284 million, and that is the direct issue of SEK 301 million minus the issue-related costs of SEK 17.3 million. By the end of the quarter, we have total assets that can be transferred to cash within a couple of bank days of all in all SEK 510 million. With that balance, the board have assessed that that will be sufficient to cover the needs for at least next 12 months. By that slide, I would like to hand over to Jonas again. Thank you very much, Anders. That concludes our presentation for the Q2 report, and we are now, of course, available for any questions. Thank you very much. Thank you. Our first question comes from the line of Adam Karlsson of ABG Sundal Collier. Please go ahead. Your line is open. Hi. Thank you for taking my questions. The first one, the obvious one, are you able to comment at all on the number of systems that are placed in labs or perhaps the number of sites where ASTar is currently being evaluated? Hi, Adam Karlsson, and thanks for that question. We have decided not to go out with that at this current period because we are at the early stage. I can say that we have several sites in Europe and also in the U.K. that are now participating in running the system. We also actually have an additional site in Sweden, which also going to be included in part for the U.S. studies for some of the reproducibility. We have a number of systems out and really are running it in a clinical setting and really pressure testing the systems. We are very happy what we see so far. We have decided not to go out with any new placements because that would mean a lot of press releases coming up. I think that will be my answer today, and I hope you can appreciate that. Yep. No, that's fair enough. Thank you. I was wondering if you could give any more detail around the planned health economic study in terms of timeline or size or define and so on or perhaps when you're looking to update us. As part of that, obviously, the commercialization has begun, although obviously in a highly focused way. Have you gotten any more sense for the weight that kind of would-be customers are placing on the in-house ASTar specific clinical outcome or health economic study? Well, yes, what I can comment on is that we are planning actually not one, but two health economic studies. We're planning to do 1 study more in the northern part of Europe, which is a typically less resistant setting. We're planning 1 study that will be performed in the southern part of Europe, where we have a bit more problem with resistance. Because we, of course, want to evaluate ASTar in the low resistance settings versus also higher resistance settings. We are in contracting phase or have actually finished contracting with several of the sites that are planning to participate in the study. We will announce more details of the study already during this autumn. I think that's going to be important, of course, for the long-term success of the system. I think it's also, in my book, very well planned to look at it at different settings because you might have a little bit different needs for a system for these two type of environments. We might all be high resistance settings in five years or so. Currently, we can see these 2 sort of poles that we would like to investigate. It's progressing well with regards to that. I think a couple of comments we have, what we can see from evaluations is customers really appreciate that it takes so little time, less than 2 minutes, around 2 minutes to load a sample, and you can actually upload it and then walk away and start doing a lot of other activities. All these labs, as of today, are still heavily involved in COVID-related testing. Of course, having that simple to use system is really a key. The second part, I think what we see is that people who have not experienced rapid AST before, they actually start seeing the particular cases where they actually react and say, "Oh, this bacteria is actually resistant. I can really act upon that." It's sort of this light bulb moment, which I think is really encouraging for us as a company developing rapid solutions to see that when the customers connect to that and really truly see this is something we can act upon, this could change the outcome potentially for this patient. I think those are the 2 perhaps biggest ones that I would like to highlight. Of course, when we look at the throughput for the system, of course, eventually when we see the 1st initial phase of conversations moving over to more of a ramp-up phase, and with the goal we have to also address a bit larger hospitals where we can see the benefits of the throughput to come out in play. I think that's really what I look forward to coming forward. So far, I would say that both on health economics and of course on evaluations, the feedback we receive is good. Of course, another important part for this type of controlled launch is that it gives you time to see, do we have any teething problems? Is there some software bugs that need to be addressed? We can actually correct that before we go broader. I think that's also very smart way to launch a system to be able to have a long-term success, because we always aim, in the 3 to 5-year scenario, with our business plan, with the way we develop our products, also looking out now, for instance, for the Isolate, where we think can be a very important key in connection with ASTar, but also a standalone product. Also quite encouraging to see that, to think about how that can also be linked into the workflow in these labs. Great. Thank you. Just on that point of follow-on product and the product expansion and so on, obviously, the gram-positive panel, you've got Isolate, the portable blood culture cabinet, and then plans for a health economic study or two studies. Curious to hear kind of to what degree are you needing to prioritize where you put your time and money and assuming all of these processes are not proceeding in parallel, what can you say in terms of where or what you're prioritizing the highest? Is there a clear order for that or, yeah. Yes. In a sense, I think that's clear. Of course, we have a lot of discussing with Thermo Fisher Scientific. They are a great partner to us and of course have extensive knowledge throughout the world in these type of labs. Of course, this is something we discuss together. When I look at priorities, and of course, you're also right, we are not a huge company. We are still limited. We can't do everything at once. We need to prioritize. I think also the successful fundraise we did enables us to accelerate some of the tracks a little bit more than we could have without the fundraise, and I think that's good for the long term. I would say that on a high level, of course, gram-positive panel sort of completing the offer is top of our list. Of course, we're already working with that for sure. Really when we look at the future of ASTar, we're really looking into, of course, Isolate market being a very interesting market. With a broad panel with true MIC results that ASTar provides, we think that that can actually bring a huge value to that market. We also have urine tract infections, for instance, quite a big group of people. I would say that the priorities are for sure within the company, and we're of course discussing them. On a high level, I would expect the gram-positive being the top one, then perhaps following on with Isolates would be the second priority as it is today. It can change for sure, but that's the working assumption. For the portable blood culture, it's a little bit different. That's something that we have seen very interesting feedback on now and when we've done market analysis, and we can really see the benefit of this product for a lot of different settings, in the U.S. and in Europe, in urban, rural areas. That's something that we, with the fundraise, wanted to be able to actually accelerate even further, because the data we have now on fully independent working prototypes is absolutely excellent. We can actually be faster on just the growth detection than the fastest standard cabinets today. That's always positive. Of course, we can use the entire time for transport also for that. That's something that we really look into and see, can we accelerate that even further, and what strategy should we then have for that? I hope that on a high level answered those questions. Yeah. No, absolutely. Thank you. Thanks for that. A question on the cost side, obviously, operating expenses, slightly higher year-on-year and quarter-over-quarter, driven by, we understand a rise in personnel costs. I was wondering if you can say anything about kind of the OpEx trajectory looking forward. Are there material additions to the cost base? Do you see further significant personnel additions during the rest of the year or, yeah, if there are any kind of indication you can provide and see if you can give them on that sort of thing. Well, on an overall level, I think it also couples a little bit to the strategy as we have discussed. I would say on the investment side, what we really focus on there is scaling up our production capabilities. When we see the market, which is not yet Europe and U.S., it might be other regions, we really see that we would like to scale up production capabilities. It's more or less a race and date-driven business. We would like to have the capacity both for cost of goods, of course, but then, of course, also to be able to meet the possible volumes that we see for this product. I think that will be investments coming up for further scale-up of production. We will see a ramp-up on personnel, for some time, I think, but maybe not a dramatic increase, so to speak. Okay. Got you. Perhaps just finally, we thought that there was an additional site, a study site added for the U.S. pivotal study. Just the rationale behind bringing in another study. Is that to do with kind of the capacity for the study site to add a sufficient number of samples given the pandemic? Is it to kind of ensure speedy completion of the trial or was it for kind of commercial reasons to kind of build relations with a potential future customer? How should we think about that addition? Yeah. Of course not, it's not really for the capacity of the site. It's really to have more ASTars being run to be able to prepare the commercial activities in the U.S. It's more to have additional sites running the system. I would say it's more of a commercial decision to do that. Of course, it will not be negative in the throughput of patients, but that has not been limiting. The sites that we have or are in discussions with, and we will announce them, they have a big throughput or big number of blood cultures. It's more to be able to be more commercial ready, when we then sort of enter the U.S. market. Great. Okay. Thank you very much. Thank you very much. Thank you. Our next question comes from the line of Alex Skoglund of Kepler Cheuvreux. Please go ahead. Your line is open. Hi. Thank you for taking my question. I'd just like to start with the European commercialization. You commented earlier that on the strategy of taking out, kind of evaluate the system and work on the bugs. You also mentioned, going into a ramp-up phase at some point. When would you expect that to happen? Yes. Hi, Alex. Of course. When we look at this, everything of course depends on the evaluation. So far, we think it goes great. What we do see is ramp up coming up during the autumn. That's currently in the planning, so we're not looking at the ramp up years to come. It's more months to come, so to speak. Got it. Let's say broadly in Europe, how long is the sales cycle? Well, of course, we don't have any numbers for that just yet. If we look at Accelerate Diagnostics, which is the first company sort of pioneering this field, I think when they started, they had some 12 to 15 month or so sales cycles. They moved it down to nine months. I think the difference here a little bit, when we talk to and have Thermo Fisher Scientific as a partner, first of all, they have deep relationships with, I would say more or less all labs in Europe. They are, of course, a big company, have very good products in this space. They have a very good traction at those labs. I think also it depends a little bit. Also, perhaps you remember that when Accelerate went out, they had cash-based sales initially. That was their focus. I think when we think about the market today, I, and of course this is my personal opinion, Thermo Fisher will of course decide, it's their home ground, but I really anticipate to see more of reagent and rentals. Of course, that type of different sales strategy, I would say, enables a lot more customers to be able to cut that time quite significantly. I think also this shows the strength with a strong partner that could offer cash-based sales, rent and rentals, or even leasing agreements, depending on the customer needs. They have everything set up already day one to be able to offer a wealth of different sort of funding opportunities for the system. Those are the numbers that we have seen from Accelerate. Of course, we think that with our strategy, they can be better. I think this is something we all have to wait and see, and over the next quarter, see what will the timeline be, how efficient can we, together with Thermo Fisher, be at taking these systems out commercially. That's probably the indication I can give. It's early days. Got it. No, that's very helpful. I was just wondering, will you be able or allowed to report at some point a commercial KPI, such as placements and consumable volume? Yes. This is something, of course, we discussed with Thermo Fisher, and we have not really decided on the pure strategy yet. We have in general, our plan is as soon as we have seen commercial traction where we can actually start seeing the trajectories, we try to be as open as possible and as open as our agreement allows. These are discussions that we'll come back to, and hopefully we'll be able to provide you with some better details there. Again, I would say early phase, and we need to really see that we do that properly, so to speak. Got it. Perhaps the last one on your menu expansion, when would you expect to talk about tests beyond the sepsis application? During the autumn, I would say. Yeah, okay. Got it. Thank you very much. That's it for me. Thank you very much, Alex. Thank you. We have one further question in the queue. That's from the line of Johan Unnérus of Redeye. Please go ahead. Your line is open. Thank you, and congratulations to the good progress as well. Mainly some clarification. Should we understand it as we can expect increasing volume sales for system towards the end of the calendar year, and then for consumable kits to follow deeper into 2022? Thanks for the question, Johan. I typically don't like to give guidance on that at this early stage. Of course, if everything turns out as we want here, and we can start seeing some broader expansion during the autumn, I think it also depends. Typically, when you see a hospital buying a system, they will start low volume. Of course, they want to familiarize, and they want to really see the system in their setting performing, which we of course expect. Of course, our goal has been then to see volumes coming up. I would not say that it's an unlikely scenario that you present, but I think that it's a little bit early for me to provide some guidance. I think it's a quite good rationale to see the systems coming out. Initially, the volumes might be lower because you really want to test them out. Our simple goal has been really the capacity of ASTar to enable every single positive blood culture that's unique in that hospital to be run on ASTar, and that's definitely still our goal. I think that every patient who presents bacteria in the bloodstream, they are a sick patient. They should be provided with rapid diagnostic solutions. I think that's really our goal here. Of course, also long term, having a high capacity and full automation, I think also enables us to address some of the larger hospitals and institutions that have really big volumes but really run their lab as a business, meaning that you really need to see how much time do you actually spend with manual staff versus automation. I think that's really an interesting customer category to me personally, also. Interesting. Also during the call, we get the impression that you are probably likely to progress with the Isolate opportunities and the portable opportunity more or less in parallel. Is that correct? The portable technology, for sure, we are really working with that, and I think the fundraise enables us to make the right decisions there. I still think that our priorities first will be the gram-positives. As you know, ASTar today can perform Isolate analysis. That is more also timing on when do we think the right study is to do a clinical study for that. We are, of course, always also looking into, there are a number of new antibiotics or antimicrobials sort of entering the market. We want to have a goal to be able to provide these new drugs, so to speak, early on. That might mean that you want to wait a little bit, for instance, for the Isolate to be able to include those drugs. I think the gram-positive is still the absolute highest priority now, since we also know what ASTar can perform on isolates. It might be a strategic decision that we will sort of set during the autumn and be able to come back to you also with perhaps some clearer guidelines on really what's the order of the next sort of expansion on ASTar. Excellent. Finally, clarification on the health economic studies. Is that something that we should expect feedback on deeper into 2022, or? I would say so. These studies are, of course, quite big. You want to have statistical power in those analyses. I would expect output from those studies during next year. Yes. Also the range of indicative cost benefit is rather broad, and that probably also reflects different categories of patients and perhaps also acute patients and the like. Will you include different categories in these studies? Yeah. Without going into the details, typically what you see is an ICU patient or an ER patient. Those are the biggest category for sepsis. I think that, again, this is my personal opinion. I think it's a little bit sad if you only focus on one of those groups, in a sense, because you might show some benefits but you might actually lose benefits from the other group. I think it's at least important to think about how do you address these two big groups. It might be different when you have a high-resistance settings versus a low-resistance settings. You might want to plan the studies a little bit differently. That's at least how we think about it. I think that you are right, and I think also, to be fair and honest, we are now planning two studies to be started. We see that health economic studies is going to be a continuous work within the company to expand to further sites, other geographies, maybe pinpoint some specific categories. I think health economic studies is something we're going to run for many years. Of course, we want to start and stop the study to look at the results. I think this is a very important value also to provide some data to the hospitals on where could you improve the most, where does it really make most sense for ASTar today depending on the setting, and where do you think you should plan to go next. I think we have Dr. Tiziana Di Martino, who is responsible for the study planning, and I think she's done an excellent job in pinpointing, finding the right measurements for these various studies. At this point, we won't disclose really the details of how we plan the studies. Perhaps for obvious reasons, we are not the only company thinking about this, and I think we have a good strategy, so I would like to keep it internal for quite some time. Thank you. That's very useful. Finally, something that perhaps we should know already. A larger health economic study, can you remind us what sort of an indicative cost range can be expected without taking that as a future factor of your particular study? I think it depends a little how you look. Large studies can be 30 and 40 sites. I don't think that's how we want to start it. If we take, for instance, if you compare it to a clinical study as we perform now, for instance, then I would say that those are in the order of SEK 30 million to SEK 50 million or so. Majority of those activities are analytical part of the study, and maybe a third of that is coupled more connected to the hospital costs. Maybe that could give some indication. Of course, it all depends on how many sites do you want to include in the study. Here, I think we, the same as we launch, we want to start with fewer sites, which are very representative to their respective category, but still large enough to provide statistical power. I think when we come out in the out years, we might want to extend them to a little bit broader sites. I think that the study cost initially for health economics will be a little bit lower now. Of course, as also volumes and margin grow, we might want to plan to do some larger scale studies. Maybe that could provide some indication on what we think about the cost of the studies. Excellent. Thank you. Thank you very much, Johan. Thank you. As there are no further questions at this time, I'll hand back to our speakers for the closing comments. Thank you very much for that. It's been a very, as I said, interesting quarter. I think we had some very good questions. I do hope everyone can stay safe because the pandemic, as you know, is not over. Please vaccinate yourself if you haven't done so. It's important for the world. I also hope that all of you will have some well-deserved vacation in a nice weather, wherever you would like to spend it. With that, me and Anders would like to close the call for our Q2 report of 2021. Thank you very much. Thank you.