Welcome to the Biovica International Market Update FDA clearance. For the first part of this call, all participants will be in listen-only mode, and afterwards there will be a question-and-answer session. Today, I'm pleased to present the CEO, Anders Rylander. Please begin your meeting. Thank you, Gary, and welcome everyone to this market update as a result of our recent 510(k) clearance. If we switch to the next one, slide number two, you see the team that I have brought together with me today to make this presentation and give you some background about the clearance and the process going forward. It's me, Anders Rylander, as the CEO, and together with me I have the regulatory and QA, Joakim Arwidson, SVP Business Development, Henrik Winther, and Warren Cresswell, President of Biovica Americas. If you move on to slide number three, you will see the agenda for today. First of all, I'll just give a very short introduction about the company and the product. Joakim will take us through the 510(k) clearance, what it means, and some details about it. Henrik will talk about the clinical application, what this clearance gives us in terms of that. Warren will take us through the U.S. go-to-market plan that we have been working for quite some time and now are finishing up in order to bring the product to the U.S. market. After Warren and my short summary, we will open up for a Q&A session. If we move on to slide number four, starting with Biovica overview, I'll just mention that the company is founded in 2009, and it is sprung from research performed at Uppsala University, focusing on enzymes related to the cell proliferation cycle. The company IPO'd in 2017 and is currently being traded on the Nasdaq First North Premier. We have our headquarters in Uppsala, where we have research, development, production of the assay and also commercial resources for the European markets. In the U.S., we have established our headquarters in San Diego, where we both have a commercial team and a lab offering the product as a service to the US market, which Warren will talk a little bit more about in his presentation. On the regulatory side, we have since many years the ISO 13485 certification, which is our quality system and which is prerequisite for getting different regulatory approval for different markets. We have CE, the product DiviTum is CE labeled since many years, which is required for use on the European market. Now, we receive a 510(k) clearance for the US market, which we'll talk a little bit more about in detail on the upcoming slides. That was a very, very short summary of the company. If we move on to slide number five, we have a short summary of the product as well. The product name is DiviTum, and it stands for dividing tumor, and as the name indicates, we're measuring cell proliferation. As you all know, cell proliferation is essentially what defines cancer or uncontrolled cell proliferation. By measuring cell proliferation, we can provide very important information both for the treating physician and for the patient, giving a quick feedback on the aggressiveness of the disease and also during treatment, how well the patient is responding to the treatment in terms of how the cell proliferation is affected. Currently, these patients are being monitored during their treatment with imaging diagnostics, which requires an image both before and several months into treatment. With DiviTum, there are several advantages. One is that it's convenient with a blood test, and another one is the quick feedback that we can provide on treatment. We've shown in clinical trials that we can see significant changes only two weeks into treatment. Also another clinical trial has shown that DiviTum in median can detect progression almost three months ahead of the imaging diagnostics. We believe we have a product that is superior to the current best products that are being used. We also will show some data during the presentation to support that. If we move on to the next one, slide number six, we have Joakim Arwidson. Maybe Joakim, you can introduce yourself and your background before moving into the 510(k) clearance. Yes. Thank you, Anders. I'm Joakim Ardwidson, and I'm very happy to present our 510(k) clearance. First, a few words about me. I have been working as Vice President for Regulatory and QA at Biovica since 2021, and I've been in the medical device industry since 1995 and have similar positions in other companies with a focus on regulatory. Apart from IVD, I will also be working with theranostics and molecular imaging. In total, I have done actually 15 510(k) applications where we have success. The last one here with DiviTum TKa is the one I'm definitely the most proud of. Even if the pandemic had a big impact on the time for FDA to complete the review, we had a very positive and good communication with FDA throughout the project. FDA realized early that this product has a value for the patients, which has also been a very good motivator or an extra motivator for us in the team. If we move to next slide. This is. Yes. We received the 510(k) clearance, the 29th of July. What does the 510(k) clearance mean? This means that Biovica now can legally market DiviTum in all of the states in U.S. The marketing must follow the DiviTum's labeling and indication for use, which states the reason for the product's use and condition, like, it's like the disease and the patient population. As I mentioned before, throughout the project, we had a very good collaboration with FDA and which also understood early on the value of DiviTum and for the patient population. If we move to next. The predicate device. When you work with a 510(k), you always need to identify a predicate device. The predicate device is used to demonstrate the device to be marketed is as safe and effective by proving substantial equivalence to a legally marketed device. For Biovica, it was Pre-Sub meeting was held in 2017, and then Biovica was recommended by FDA to use CYFRA 21-1. That's a device from Fujirebio that had a 510(k), and which was the closest in comparison to the indication for use for DiviTum TKa. Actually, this Pre-Sub meeting saved us a lot of time, otherwise, to the regulatory path, have ended up in a De Novo application or PMA. However, the method, disease, and patient population differed between the devices and the clinical effectiveness and validation of DiviTum TKA was done through the SWOG study. We used the predicate device from CYFRA as a paper predicate device. Yes, if we move to next. For DiviTum TKa, there is also unique product code, and the name and product code identify the unique category of the device. In normal cases, when you have a 510(k) application, you use the same code as for the primary predicate device. Based on PMA or De Novo applications, the FDA usually creates new product codes. However, in this case, DiviTum TKa was unique, and the code QTE was created by the FDA, which we are very proud of. The definition of QTE is for the device, it's the thymidine kinase activity. The definition is in vitro test to measure thymidine kinase activity to aid in monitoring disease progression of breast cancer patients. The conclusion, DiviTum TKa is the first in class. Next page. In parallel with the 510(k) process, we also proactively adapt processes, production, and post-market to be in compliance with applicable rules and planned audits by FDA. This includes everything from GMP, like the good manufacturing practice to be in compliance with the Part 820. Also, of course, to the end, like the medical device reporting, tracking of the device, and so on. We are working a lot with to have the system FDA readiness in the organization. How to extend the indication for use. If we don't do any changes, we don't need to redo the analytical validation. With additional clinical data, so can we expand use, and we will have a good platform to work from. That was my last slide in the presentation, and I'm handing over to Henrik for further presentation about the DiviTum as a clinical application. There you go. Thank you. Thanks, Joakim Arwidson. My name is Henrik Winther, and I'm heading up the business development at Biovica, have done so for the last 2-3 years now. The reason for me to participate on this meeting here is really that I have been heavily involved in the DiviTum TKa clinical validation study and the 510(k) process. That's due to my many years of experience with analytical and clinical validation of biomarker assays, and also my experiences in bringing them through FDA at all classification levels. That being both Class I products, Class II or 510(k) products, and also a couple of Class III or PMA products. Next slide, number 12, please. Listed here you see, you know, the two topics I'll cover over the next four slides. Initially, I go through the key takeaways with regards to the FDA cleared clinical utility of our DiviTum TKa assay, and then afterwards I'll provide some clarification to some of the frequently asked questions with regard to the assay clinical application. Next slide, please, number 13. Let's start by looking at the five key takeaways from the FDA cleared intended use of the DiviTum TKa assay. Number one takeaway is that DiviTum is a completely new way of monitoring hormone receptor-positive metastatic breast cancer patients, which is reflected in what Joakim said, you know, FDA providing a unique code to the assay. In contrast to imaging, our assay monitors metastatic breast cancer patients through blood samples. Secondly, in the clinic, the assay will assure the patient and the oncologist that disease progression has been inhibited, which is the same as saying that the patient treatment is effective. Thirdly, the assay is recommended to be used on a monthly basis, the first seven months after treatment initiation, and then quarterly. This is actually also what we originally assumed in our calculations of the market potential of the assay. Key takeaway number four is that the assay application is cleared by FDA, which means that the assay application is not restricted to any specific anti-proliferative treatment, but can be used together with today's standard treatment in hormone receptor-positive MBC patients. This assumption was also part of our market potential estimation. You can say, the key takeaways number three and four really confirms our business case on the number of expected tests per year. Next slide please, number 14. Last key takeaway relates to the performance of the DiviTum TKa assay. FDA was very impressed by the assay's high NPV, which actually became a key driver for FDA in getting the assay out in the clinic. So what is this NPV or negative predictive value? Well, NPV of the DiviTum TKa assay reflects the likelihood of a negative test result equaling no disease progression. With DiviTum TKa, a negative test result is equal to a 96.7% likelihood of no disease progression within the next 30 days if you stay on your current treatment. This is obviously very useful to the patient and the oncologist. With a monthly DiviTum TKa testing, the oncologist can monitor and assure the patient of a continued effective inhibition of disease progression. We actually also looked at a time frame of 60 days beyond assay testing, and also here the assay provided an impressive NPV of 93.5%. If you are test negative, the likelihood of no disease progression over the next 60 days is 93.5%. Those were the key takeaways. Now we switch to the key clarification. Next slide please, number 15. Here in the next two slides, I'll focus on making clarifications to some of the typical questions we have received following the 510(k) clearance. Let's start by looking at the assay's clinical specificity and sensitivity. An assay's clinical specificity is the assay's ability to correctly identify those patients without disease progression. In the clinical validation study, holding a total of 1,164 patient samples obtained during treatment, 1,101 samples showed no disease progression within 30 days, and 888 of these, which equals to 81%, were correctly called by our DiviTum test, and they were called by having a low TKA value, meaning below the 250 cutoff. When looking at no disease progression within 60 days after testing, the clinical specificity is 82%. Now, if we turn to the assay clinical sensitivity, which is the assay's ability to catch disease progression, we have a couple of comments here. When we designed the assay and when we carried out the clinical validation study, we did not focus on the clinical sensitivity because we were aiming for a high specificity and a high NPV. We also knew that the clinical validation study couldn't provide us with a fair estimate of the clinical sensitivity. The reason for this is to be found in the way the clinical validation study made decisions regarding disease progression. In the clinical validation study, imaging, especially of CT scans, was used as the truth when it comes to deciding upon disease progression or not. We also knew that CT imaging will only state progression if you have a tumor volume increase which is above 20%. Otherwise, the CT imaging technology is not safe enough to conclude on progression. DiviTum is measuring cell proliferation, and we pick up disease progression much earlier than volume-based imaging, which has been shown in other studies. For example, the PALBO-DOSE study, which we reference here and which we have also discussed in earlier calls. When you use imaging, and especially CT scans, as the truth in your 2x2 tables to calculate DiviTum's sensitivity, the assay will be judged incorrectly because many of the progressions detected by DiviTum are truly progressions, but they are not detected by imaging. If you actually dive into some of the materials which is out there on the FDA homepage, you can actually find this 2 x 2 table. If you by yourself move the false positive samples into the true positive, you will find a complete different clinical sensitivity of our assay. Actually, obviously our specificity will also go up. The clinical sensitivity of the assay has to be established using better ways of evaluating progression, which means using a combination of different imaging technologies, CT plus PET, biomarkers, and patient symptoms, just like they did in the Palbo-dosing study. Next slide, number 16, please. The last clarification relates to a sentence that FDA asked to be included in our instruction for use because FDA asked us to state that the assay can't be used for serial testing. Now, it's important to understand that the term serial testing is a specific FDA term. It really has nothing to do with the number of tests we recommend to perform. Hence we can still recommend repeat testing and testing on a monthly basis as approved by FDA. The FDA serial testing term describes a test in which you need to perform two tests in a row with a certain timeline in between, and where you compare the two test results and look for a certain percentage change in your measurements because you have based your cutoff on this certain percentage change. DiviTum is not such a test where you need to compare to a former test result and calculate percentage change. Therefore, FDA wanted to clarify that in our IFU. DiviTum uses a fixed cutoff at 250 DuA based on the expression of TK in a normal healthy population. As a user of the test, you don't have to store results from a former test or perform calculations to find the percentage increase. We believe this is safer and easier. Thanks for listening, and over to you, Warren. Hey, thank you very much, Henrik, and good afternoon, everyone. My name is Warren Cresswell, and I'm the President of Americas for Biovica. I've had the pleasure to work in the diagnostic industry for almost 25 years in device, PMA, 510(k), as well as CLIA lab market with laboratory developed tests and have developed high-value multi-analyte algorithm-based assays. As of August first, I celebrated my one year anniversary with Biovica, and with that, I'm very excited to share the progress we have made in the U.S.. If we can advance to the next slide, number 18, titled US Update. Great, thank you. Today I'm gonna touch on four core areas of the business, which include the CLIA lab, sales, marketing, and reimbursement. If you can advance to the next slide 19, labeled US CLIA Lab. I'm happy to report that in a short duration of time, we've made significant progress with our CLIA lab. In late Q1 of this year, we signed a lease for a laboratory property located in San Diego, California. In April, we hired our head of U.S. operations and regulatory. Soon after that, we contracted with our medical director and our clinical laboratory scientists, which are positions required to apply for and operate a CLIA lab. With both positions, we signed consulting agreements so that we could minimize operating expenses pre DiviTum launch. In light of supply chain delays, we were able to creatively source and install all necessary laboratory equipment. With the help of our colleagues in Sweden, we were able to draft and implement our U.S. quality system. Not only does our quality system align with the standards in the U.S., but we wanted to ensure alignment with our organization in Sweden. During this timeframe, we developed a blood-based collection kit that will be manufactured and distributed from our San Diego facility to serve U.S. customers. As of this week, we have completed the validation and verification of all lab equipment. Our next step is to submit our CLIA lab application to the California Department of Public Health, which we will do in the coming weeks. As of today, the application process is about 95% complete. According to our last communication with the California Department of Public Health, once an application is submitted, the lead time to receive certification is 4-6 weeks, provided there are no unforeseen delays. We can advance slide to slide number 20, titled U.S. Sales. Our focus in the U.S. organization pre-launch has been on commercial readiness. We want to ensure that we are ready to launch DiviTum. We have people and processes in place without incurring unnecessary cost. When we hired our U.S. head of sales in February of this year, we quietly initiated a recruitment process to identify high caliber sales professionals that had overlapping experience with our specific needs and had the motivation and commitment to learn about Biovica, DiviTum, the unmet clinical need, read and study peer-reviewed publications, develop territory strategies, and other critical factors that will enable them to be productive almost immediately upon hiring. We also constructed a sophisticated customer targeting strategy to maximize salesforce effectiveness. This highly targeted approach uses several variables to ensure we're focusing time and energy on the highest value opportunities. Some of the value variables for our model include key opinion leaders and regional thought leaders, institutions designated as NCI and NCCN centers. Existing relationships are very important, especially with the folks from Biovica and also with new sales reps. We did acquire drug prescription data, so we do know quantities and types of particular drugs that are prescribed by physicians and specific institutions. We have information on payer reimbursement mix as well as valuable for us to understand the mix of public versus private insurance and what specific health providers or specific geographic regions. High density regions, as we wanna maximize the number of daily sales calls and minimize travel costs, and institutions where blood sample access channels are available and cost-effective. Taking this highly targeted approach is not only a tool for our salesforce to be successful, but it also enables us to measure performance and improve our targeting model. Can we advance to the next slide, 21, titled U.S. Marketing? For approximately the last six months, our marketing efforts have been focused on launch readiness. Some of the critical materials we're focused on designing and developing include test requisition form, test report, interpretation guide, sales aids, product information, and promotional slide deck. We also recently conducted market research with medical oncologists, where we had 15 one-hour interviews. After discussing the role of TKA in the cell cycle, oncologists believe that TK, thymidine kinase, had an important role in managing patients with metastatic breast cancer. Moreover, when we shared our data and our very high NPV, most oncologists believe that there could be multiple clinical utilities for DiviTum. This we felt was very exciting. It should be noted that together with our global clinical team, we're very focused on continuing to build and strengthen our relationships with key opinion leaders and regional thought leaders, as they are critical to our success. At launch, we will also engage and collaborate with regional and national breast cancer advocacy groups. As we feel very strong about the clinical benefit of DiviTum, we want to bring awareness to patients. If we can move to the next slide, 22, titled U.S. Reimbursement Strategy. Our reimbursement strategy takes a three-pronged approach, which we will execute in parallel. At launch, we will immediately engage our Medicare Administrative Contractor. These are also known as MACs. We will initiate the process for DiviTum to have a technology assessment and determine if a similar assay that have received a local coverage determination, also known as an LCD, aligns from a technology perspective with DiviTum. If the MAC agrees that there is similarity with another assessed assay, we can essentially piggyback on that assay's LCD and qualify for reimbursement in a very compressed timeframe. We'll also file for a proprietary laboratory analysis or PLA code, which will be unique for DiviTum. The benefit of this is the ability to list DiviTum's PLA code and approve reimbursement on CMS's National Fee Schedule. The PLA strategy also aids us in getting reimbursement with private insurance carriers, and it should be noted that this represents approximately 50% of our total available market. At the same time of launch, we will drive value-based collaborations with hospitals and general reference labs. With these collaborations, the institutions leverage their existing agreements with payers to obtain reimbursement. This methodology enables Biovica to invoice these institutions for services rendered rather than private insurance companies. This process not only provides payment certainty to Biovica, but eliminates the need to engage private insurance for payment. This process opens channels for oncologists to send patients for blood draws. We believe that 25% of our total business can be driven through this channel. Concurrently, through our revenue cycle team, we'll engage private insurance companies and submit claims under a miscellaneous code for reimbursement. Until we're able to obtain a coverage decision from private insurance providers, we will provide medical necessity and exercise the appeals process for payment to Biovica. In this particular channel, we will also offer a patient financial assistance program to minimize financial burden to patients, and we anticipate this channel to represent approximately 25% of our business as well. With that being said, I'll hand it back to you, Anders. Thank you very much, Warren. If we move to slide 23 and then directly to slide 24. I'll just say a few words to summarize this before we open up. Hang on. I think we have a sound issue. There you go. Sorry for that. I hope the sound is back now. On to slide 24. I'd like to summarize by saying that we have a very exciting product that addresses an important clinical unmet clinical need and can really make a difference both for patients, physicians, and for healthcare providers. This has also been confirmed by some of the leading key opinion leaders within this field of breast cancer. Together with them, we have done several collaborations, have generated strong clinical evidence. To date, it's more than 20 trials being published with DiviTum, supporting the value of the product. That's, of course, also a really important foundational factor for us, being able to go through the regulatory process as we've done now. Our first application will be for metastatic breast cancer or for monitoring of patients with metastatic cancer as they're being treated. We already have clinical evidence supporting a wider use over time. Milestones, of course, the 510(k) clearance that we've gone through today is a huge one for us as it opens up launch of the product on the single largest market, which is the U.S. market. As Warren talked about, we have a plan which we're executing now to be able to launch the product in U.S. before end of this year. The next step for us is in the beginning of next year, 2023, we expect to announce and to launch also the first European market that we'll launch the product. Thank you very much, and we are now taking questions from the audience. Thank you. If you have a question for the speaker, please press zero one on your telephone keypad. I remind you that if you want to ask a question, please press zero one on your telephone keypad. We have no questions on the telephone lines at this time. Please go ahead, speakers. Yeah. We have had some questions from the web, and I'll read them, and I'll see if we can. I think we can answer them here also. The first question is from Jacob Lemke, and he asks, "It sounds like the cutoff value is important for the performance of the test. Is it possible to say anything about what the value is or how it is determined?" Maybe, Henrik, if you could answer that question. Yes, absolutely. Yeah, I totally agree. The cutoff is extremely important for an assay and, you know, where to set that cutoff. That goes back to, you know, sensitivity and specificity, obviously. Also we look at what the expression of TKA is in a normal population. Then we look at the 95th percentile, you know, of a normal population, and we use that as a way of setting our cutoff at 250 DuA. DuA is our measuring unit that we have defined within Biovica. Thanks, Henrik. If you pass on the phone to Mike. Thank you very much. The second question from Jacob is there, if there's any particular customer segments that you will target initially, or identify as potentially early adopters. Warren, maybe you could elaborate a little bit on that. You covered it briefly in your presentation, but maybe you could give us some more background on that. Yeah, absolutely. Thanks for the question. You know, certainly we'll use our model to be able to identify which are the highest value oncologists and institutions to call on. But I can tell you most likely it's gonna be key opinion leaders that we have worked with, key opinion leaders in the field, and institutions that are most likely NCI and NCCN institutions also. All right. The third one from Jacob is if we have any internal targets in terms of sales, testing volumes, patients tested, et cetera, for the first fiscal year. I can shortly answer yes on that one, but I guess there's a follow-on question, is that something that you will communicate? We can say yes on that as well, but not at this point. What we have communicated so far is that our three-year goal is that three years after launch of the product, we should be able to address 15% of the identified market potential. We can say that this process with the FDA clearance has strengthened our belief in that since it has verified the market potential, and we have also continued working with both key opinion leaders and payers in the U.S. And received positive feedback as Warren explained. We will, of course, bring that back to the further detail our plans and break down to more detailed targets as well. We'll come back to more details, but still, the 15% market potential after three year remains, and it has now been, say, further verified. All right. We have another question from Johan Unnerus here at Redeye, and he asked, Warren, this is for you, "When can we expect visual support from the Medicare segment?" You touched upon this in your presentation. Maybe you can elaborate a little bit further. Yeah. When we engage the Medicare Administrative Contractor, we would anticipate being able to get feedback relatively quickly, and that's a matter of months. Most likely within probably about a three month period, we would receive back pretty firm information back from them that would give us some visibility on coverage. Just from a point of clarity, it wouldn't mean in three months we would gain coverage from Medicare, but we would certainly receive information back from that. Most likely, coverage would come in a timeframe of kind of 6-12 months. All right. We have another one from Johan, which is also maybe something we can comment on. What's your latest feedback regarding the pricing? I can start, and maybe you can follow on, Warren. What we have communicated when it comes to pricing the market potential estimates has been based on a range on the U.S. market on $300-$500 in average price. It can in different categories, as Warren described, there are different customer categories that have different price levels on the U.S. market. We have estimated an average price on these different categories. That has also been verified since before in a health economic model that has been published, peer-reviewed and published since before verifying the price levels. We have had also further discussions with players in this field in the U.S.. I don't know if you wanna, if you have to add something to that, Warren, please do. Yeah, absolutely. You know, I think with each channel, there's gonna be a little bit of a different price. From a Medicare perspective, there will be negotiations with Medicare just like there would be with private insurance or hospitals and institutions. I think once we engage Medicare, then we'll have a very good feeling for, you know, what that Medicare price is, which will cover 50% of our total business. You know, most likely, as we submit claims to private insurance and provide medical necessity, and along going through the claims process, the reimbursement may be a bit less until we are able to get coverage directly from private insurance. I would assume that most likely the negotiations with hospitals and general reference labs should be in alignment with Medicare as well. All right. I think that was it. All right. That was our last question. I'd like to thank. I know that it's been a big audience, so thank you very much for all your interest you've shown in Biovica and the great milestone we have achieved. I'm looking forward to keep you updated on how we're progressing with the exciting times that we have ahead now going forward. Thank you very much.