Between the life science team and the tech team. Scandion Oncology is one of these promising companies in this area, and they have a major challenge and can solve one of the real issues in cancer care, and this is the issue of cancer drug resistance. We're looking forward to hearing more about this, and the floor is yours, Bo Rode Hansen, CEO and President of Scandion Oncology. Thank you very much, Johan. First of all, let me say that it's a pleasure to be here. A very warm welcome to this very first Capital Markets Day, which is in a digital format for Scandion Oncology. My name is Bo, I'm the President and CEO of the company, and I came on board almost a year ago, 11 months ago. I thought it's a great opportunity to actually host a Capital Markets Day, and today we're doing that here in the Redeye setting. Scandion Oncology is focused on one of the major problems in medical oncology. It's what we get up in the morning. This is the reason why we come to work. This is the reason why we strive every day. It's really to change the fate for patients suffering with the fact that they have become resistant or are resistant, their tumors are resistant to the existing cancer therapy. I will start my presentation in what I would say probably the most boring way, a disclaimer, but it's mandatory. I will be bringing, and the presentation will be bringing forward-looking statements. Stay tuned. Now, what I was talking about in the beginning is really the centerpiece of the problem. 90% of the 10 million, almost 10 million cancer deaths annually is due to resistance in the tumors towards the existing therapies. This is a big challenge that we have taken on. We are today giving you a view on how we see that actually going all the way to the market, going all the way to actually making a difference for patients in need, and thereby also returning a lot of value to the patients and to our loyal investors and shareholders. Let me take the opportunity to welcome you all to this journey. Shareholders that has been with us long, shareholders that has been with us from recent, and also hopefully a lot of new shareholders coming in. When we talk about cancer drug resistance, we tend to forget that we probably all know someone close to us in our life who has suffered from the devastating fact that they come into the diagnosis room, get a cancer diagnosis. That's what happens. There are treatments out there, unfortunately, a great number of these patients end up in a situation that they get the message, sorry, but there's nothing more we can do for you. There's nothing more than we can help you with some palliative treatment. Maybe some of us has even accepted that that's a fact of life. I haven't. The company and the folks around me haven't accepted this. Cancer can be beaten, that's why we are tackling it at one of these points, the resistance that appears in the tumor. If we look at a cancer patient, this is what a cancer patient could look like. I can say that when I saw the data from our first clinical trial, the data from our CORIST trial, it's a limited number. I won't be here drawing hard conclusion on a limited number of data. I know what data looks like. I know what encourages me. When you see patients that have been in a trial with Sorry, there's an echo here. Apologies. When you've been in a situation that you've been through the various treatment lines in metastatic colorectal cancer, being first line of therapy, second line of therapy, coming on to third line of therapy, progress from that, come into a trial where an experimental drug that is set out to revert cancer drug resistance is being given to you, your life expectancy doesn't look good. Maybe, this is not hard science, maybe you have two months. When I start seeing patients on that trial continuing for more than 100 days, for more than 200 days, I get encouraged. I think we are on to something which starts crawling, walking, running towards changing cancer drug resistance. This is what brings me and gets me excited about this. So let me take you through the journey. I said it's been almost 12 months since I came, and where were we a year ago? Well, in headlines, we can say that one year ago, the board had seen early data based on a promising technology, and we were running a company that was on a very shareholder-friendly shoestring budget. Let me tell you, it takes resources to create a medicine and to return massive value both to patients and to shareholders. There was a decision to actually accelerate the company, and thereby maturing the company with the first clinical trial, SCO-101 had just entered the clinical stage at that point. Where are we today? Well, I'm happy to say that since I came, we managed to stick to the timelines that we had reported. We successfully reported on an interim readout from our CORIST data. We have focused a lot on what it takes to actually build the structure and the organization that can take this company forward to the ultimate goal. As I say to my team, if you want to fly to the moon, there are different ways you can do it. You can try to practice your jumping. We can stand up and practice jumping every day. It won't get us there. Maybe we should get some people who knows how to build a rocket, who knows about flying in space and going to the moon. That's why it's been very important this year to build our organization in a successful fashion for the journey. We have also internationalized the company. I'm looking very much forward to talk about that. We have a cash position to take us to the next phase here. What I want to say is that we have created the clarity of purpose on what we want and how we're going to get there. Where is it we want to go? We want to become a phase III company. This was in our message this morning. Becoming a phase III company requires that you have some possibilities for that. We have two shots on goal, both with our CORIST trial, but also with our PANTAX trial. We want to utilize data. We want to be data and science-driven. We are utilizing the data we are finding in our CORIST trial to maximize the possibility, increasing the probability of success, and thereby lowering the risk, and again, de-risking the program and the path to a final product. We want to do that by using the knowledge we have, the mechanism of action of SCO-101 together with irinotecan to actually position us in that direction. We all think that that can be utilized in what you can call the gold rush towards immuno-oncology that opens a whole new avenue for this company. The unique potentiator that we see in SCO-101 will be used in order to create significant benefits, increase the outcome for patients, and thereby hopefully transform a corner of cancer therapy that needs to be transformed. Thereby, we will become the cancer drug resistance company. This is a leading company in combating cancer therapy resistance. Where are we? What does the company look like? If there are hopefully new spectators to the presentation today, I already spoke to our vision. We want to bring new medicines to patients in order to overcome cancer drug resistance and improve lives for both the patients, but also for their families surrounding them. We have two clinical programs ongoing. One is in phase II, and one is currently in phase I-B, and we are expecting a readout from that this year. We are also not a one-trick pony. We're going to build up a pipeline in a fashion where it will be data-driven based on facts that we know about mechanism of action. We will go broad. We can apply our technology to different cancer indications. We are not just focused on metastatic colorectal cancer, but eventually we will go into other indications. This is the platform potential that exists with a potentiator like SCO-101. We have some experience to base that on. We are building it on experience, track record experience in medical oncology, in pharmaceutical development, and with the 15 staffers we have in the company at the moment, we are portraying more than 150 years collective experience in all these areas, and probably closer to 200. Where do you find us? Well, our 7,800 shareholders are trading on Nasdaq First North, and this is where you can find the share. We have, as I said, a good cash position taking us into 2023 with the current plans. Why is it that Bo is up here talking about all this? Is this just me saying that we need to do something about this? I thought it was relevant to bring in a quote from the recent president campaign or election in the U.S. You probably all saw that. We all know Joe Biden. He's now the U.S. president. Let me remind you that one of the statements he made in his campaign is that Joe has promised us that if he was elected president, we are going to see the single most important thing that changes America, and I think America is the world's largest superpower, also the world. We are going to cure cancer. That's a pretty bold statement from Joe. My question to Joe is, well, how are you going to do that when 90% of the patients become resistant to cancer therapy? His fellow citizen, Richard Schilsky, who we are pleased and happy and honored to have on our clinical advisory board. Dr. Rich Schilsky is an American. I don't know if he has any connections to Joe Biden. I haven't discussed that with him, but Rich has said, the mission of the company that you're leading here, Bo, is clear and important. This is important stakes to take in mind. With that as a prelude, let me tell you what is new here today. First of all, we haven't spoken much about the mode of action, the details from our CORIST trial. We find a unique mode of action documented for SCO-101 in the CORIST study. This allows us, it brings us to focus. Focus is important. The CORIST data triggers an even more focused strategy. First thing, we are setting up a strategy that can take us and will make us a phase III company. We have plans for how we will enter into pivotal trials and making and transforming this company to a phase III company. We will refocus from what we are doing now, which is in last line and beyond last line in metastatic colorectal cancer, aim for second-line approval, which adds significantly more value. It's a higher bar, we are there to go for it. We are also providing the first very clear target product profile. It's easy to say that you want to do all kinds of things in cancer, you need to identify a target product profile for the first product that you are taking on. We are positioning in terms of where are our patients, how many are there, what's the demand. We are prioritizing such that we are focusing on SCO-101 in combination with irinotecan, where we have proof of the mechanism, where we have a smoking gun, over other projects that are less well-documented at the moment. This is simply to give everybody the best shot on a fair value creation, and the most value creation from a probability of success perspective. This also means that you can't do everything. We will cease certain activities in order to use our funds cleverly. We will cease investing in less documented mode of actions, maybe take them back to the drawing board and get more data instead of rushing into clinical development with something where the probability of success is uncertain. This also means that the combinations with anti-estrogens and indications outside cancer, where we don't have the expertise, are being put to a halt. We have defined a clear roadmap and how our coming years will look. In essence, I like images. There are a lot of birds there in the sky. You probably all know this metaphor. We have brought birds onto the roof of Scandion Oncology. For me, it's very important to get birds in hand. We will continue to bring birds from the roof into the hand, but we need to focus on the first bird in order to prove our success. When we talk about how I will frame this, it's about creating clarity. You build it up in a way that data needs to be sorted. You can arrange it so you can start seeing it. At the end of the day, the storytelling will speak for itself. I'm bringing a clinical strategy for winning here to you, and it's based on facts and data. It's also important to say how we are maturing the company. We are building a company to last. Everybody knows that when it comes to biotech, when it comes to listed companies, they can be swept off the planet by bigger companies that come in and buy them. You need to build a company that is attractive, a company to last, and I'm just saying that because you can't just go around thinking you will be bought the next day. We are giving you a deep dive in to see how we position in the market of opportunities with SCO-101. Then we are also, as we announced recently, we have brought in a number of Key Opinion Leaders, world-class Key Opinion Leaders, and there will be, in my mind, a very interesting interview with Josep Tabernero talking to why he thinks that this is an important mission and how the cancer field would look at this. Finally, we are going to speak about our CORIST data and the data from the trial on mechanism of action. My colleague, Maj Hedtjärn, will be here and present the details to you. Stay tuned, I think if this is the time point where you said, I've heard enough. I don't have time for this, bring these key takeaways. CORIST significantly increases my, and the company, and the board of directors' confidence that we have a unique mode of action. This underpins that SCO-101, as a first-in-class medicine, is able to take an existing gold standard therapy to potentially a new area, and it makes it even more meaningful in terms of real therapeutic benefits to patients. We are setting a high bar, and you should expect that from us, and that's why we have to stay focused on this mission. We will aggressively exploit SCO-101 and its ability to potentiate irinotecan, which is unprecedented in relation to the data that we have seen. The second take home is we envision utilizing that for making a game changer in immuno-oncology. That's a major field. Immuno-oncology has a lot of promises, but there is also a need for cytostatics and chemotherapy in that area in order to increase the effectiveness. Finally, we are also here to reaffirm that we will stick to our timelines as communicated. CORIST data from part two is expected in the second to third quarter of 2022. We are expecting our first readout with our PANTAX phase I-B in Q3, Q4, second half of this year. This was the first slide I brought to my Board of Directors when I came in as CEO. This depicts the horizons that I envision for Scandion Oncology. We are right now in the first horizon. What we are focusing on is really getting clinical POC, focusing on the business that creates value, being lean, and taking and using our scarce resources in creating value and those opportunities. We are establishing the basis for a pivotal trial, which is needed in order to get an approved therapy. We are looking at how can we then expand the pipeline, so we don't experience a cliff. We are also increasing our international business development activities. Business development is relationship creating. It's building up. I can tell you from my experience that pharma deals, they take time, and they take credibility, confidence creation, and so on. In this horizon, we are also focusing on entering one of the Nordic main markets for trading our shares. That takes us to the second horizon. Now we are looking more into the future, and let me say Horizon 1 is fully funded. In terms of Horizon 2, we are looking to initiate our pivotal trials. We will increase our presence internationally, particularly in the U.S., and we have an active strategy to increase international institutional ownership. We're also looking to expand our pipeline at that point in time, and we will start looking at what will be the strategy for commercialization of our first product. Not meaning that we necessarily will build up a commercial organization. That's not what I'm saying. We need to have a strategy for how do we commercialize it, what will be the strategic partnership, and so on. At that point in time, we will be having an NDA in sight. Finally, Horizon 3. This is really when we have our first NDA. We will have expanded our pipeline with three or more programs, and we will explore the use of other modalities, potentially, and we will have the strategy of commercialization implemented. This requires that we have the right people on the bus, and as I've said numerous times, it's the people who transform science into medicines. You can probably all imagine, you know this, the best idea in the world can get destroyed if you don't have the right team around it. You can also, with the right team, transform things into value in a splendid fashion. I focused on getting some team members in that can take the journey and take Scandion Oncology to the next level. That's why I'm also here to present the team that I have with me today. This is not the entire team, but they are here in Stockholm presenting. It has been a transformational year for us, where we have managed to hire some key talent, and let me give you a brief introduction to them and why I think it's important. This presentation is not to start with me, but this is how it was built. I think it's important to say that if you don't know me from anything but Scandion Oncology, let me say that I've been in international biotech in the U.S., in Europe. I've been part of starting biotech companies, taking them through the development, commercialization. I've been running big strategic partnerships and also monetizing in hundreds of millions of dollars to companies. I've been in big pharma. I've headed a global area of RNA therapeutics in Roche. I've been on the other side of the table, and that's why I can with some confidence say I know what a big partner would be looking for in terms of quality, data, and time. More interestingly, we've also managed to attract Maj Hedtjärn as our Chief Operating Officer and Head of R&D Operations. Maj has a track record also from SME-sized pharma companies, from very big pharma, the world's largest oncology company, Roche, and also from biotech, overseeing R&D operations and partnership operations. As you can see, Maj has also personally invested in the company, so there's a clear stake. We have managed to attract Johnny Stilou, who is here in the room and will be part of our Q&A session. Johnny is our CFO. Johnny comes with a strong track record in building financial structures and financial strategies for companies like Scandion Oncology. Johnny has this little side effect that the past biotech companies that he entered into all got acquired by big pharma companies, but it is not to guarantee that that is a rule. Johnny has also invested in the company and is here for our Q&A. Finally, we have Peter Michael, who was here. Peter Michael is our CMO, and Peter Michael is probably one of the most experienced medical oncologists that we have in Denmark. I am very pleased that he is on our team. He brings deep, embedded knowledge in the area. In terms of showing or putting his money where his mouth is or putting skin in the game, Peter Michael has heavily invested in the company as well, just to say that he also believes in the mission here. Finally, I could have gone on with all the talented people. These are the folks that are with me here in Stockholm today, but we have a very strong team in place. This is the team. We have gone from five people to 15 people, so plus 10 people in the last year. We now have the experience and the skills in place in terms of evolving Scandion Oncology. We have, you can say for now, completed the retooling of the company. I am very confident that this team is going to take the journey and take Scandion Oncology to the next level. Every CEO will say, my team is stellar. It is, because otherwise he should change it. I am extremely pleased to be here and present what is a truly stellar industry-leading clinical advisory board, probably the best in the industry. I can say that. We have Richard Schilsky, who I already spoke to, and he was introduced a while back. Dr. Rich Schilsky is a past president of ASCO, American Society of Clinical Oncology, and sort of the dominant clinical oncology organization in the biggest market, U.S. We managed to also attract Dr. Josep Tabernero, who is a European counterpart of that. He's a past president of ESMO, the European counterpart of ASCO, and he's also a very experienced gastrointestinal oncology expert. As if that wasn't enough, we managed to attract the president of the Foundation Against Cancer, and also the president of the German Cancer Society. This is Eric Van Cutsem and Thomas Seufferlein, that are first-class medical oncologists in the area in the cancers that we are developing in. I've had numerous meetings with them, and it's very encouraging to hear how they see this field and how they see the need for new ways of thinking around cancer drug resistance. Let's go to what I promised you in terms of a new strategy. Well, let's lay the grounds. Key achievements in the past year. In terms of people, I came in almost a year ago. We were joined by Maj as COO in March. We brought in Mads Jensen as VP of Business Development in April. We had Johnny as the new CFO in July. With this recent message on our Clinical Advisory Board, I think we have really built substantially on the people side. Remember, it's the people that transforms the science into medicine. In terms of finance, we did a large capital raise of SEK 236 million in December, and this is taking us into 2023. We also changed the listing of our share to a different platform at Nasdaq First North. In terms of pipeline, we have shown progress on our clinical pipeline, again, de-risking, and we have internationalized our studies. We have had positive interim data on our CORIST trial, the metastatic colorectal cancer, where we're testing SCO-101 with FOLFIRI, and that we reported in June 2021. We also opened trial sites in Germany in order to actually expand the patient recruitment and also internationalize the trial and our network. We have also shown that we have promising preclinical data in the area of immuno-oncology from our feasibility study with Alligator Bioscience. This is the foundation. In terms of what you can see here, if you should condense this into one slide, CORIST data has greatly expanded the knowledge base that we have, and this is what we are building on. We are crystallizing from there. There is apparently a clean profile on SCO-101 in terms of side effects, very important. We can potentiate the biological effects of the chemotherapy irinotecan, and we believe that we can help patients with irinotecan across other types. This is not just something we believe. We base that on where other irinotecan formulations are trailing and trying to position themselves. We have this early-stage research showing that we have a powerful tool in the immuno-oncology space. We have used data, inputs from market, from KOLs, from advisors, from consultants, and also insights from ourselves to refine and tune this new strategy based on clinical trends, which leads us to focusing on how will we maximize the value creation here for both our stakeholders, patients, and for our shareholders. This means that we are aiming for a registration as a second line of therapy. This is a much higher bar than a third line. We seek to broaden our application across cancer indications within irinotecan, and we also will exploit the area of immuno-oncology. What was it that we learned from part one? Well, first of all, just to reiterate, FOLFIRI, that we combine with, is a combination of folinic acid, fluorouracil (5-FU), and irinotecan. Irinotecan, which is the centerpiece in there, is metabolized into an active ingredient called SN-38, and you will hear more about that. It's SN-38 that's really the potent factor in here. This has been used, first registration was in the U.S. in 1996. This is a format that's been around, it's well-tested, but it's still the backbone in many ways in therapy in metastatic colorectal cancer. It's given as an intravenous infusion. Today, it's a generic, and when we look at the forecast, the expectations and the outlooks all point in the direction that this is on the increase, unfortunately. There's still a strong need for therapy in metastatic colorectal cancer. This unique mechanism of action that I've spoken about, I have a couple of cartoons. This is not hardcore science, but when you have irinotecan in circulation, so it's injected, there are certain enzymes involved in metabolizing it, UGT1A1. Also in the cancer cell, ABCG2 is a pump that expels the active ingredient here and thereby protects the cancer cell. What we have found is that SCO-101 inhibits both of these trigger points in the body. This means that it's almost a double whammy, and Maj will speak much more and show you the data. I think it's important to understand that this is a unique mode of action that is unprecedented. No other drugs that we know of can do both these things. If you would look at it in a metaphoric fashion, you can say you have UGT1A1, which controls the influx of this active ingredient. This is the uphill river coming down as a waterfall. This runs into a puddle, which is the available SN-38 that can kill the cancer. You should imagine that what is underneath this lake is the cancer. It works somewhat, but as the cancer has resistance, it also has ABCG2 that lets out the water again. What SCO-101 can do is that it can add a block to UGT1A1 which really opens the funnel upstream. There is an increase of water into the pool, and at the same time, it blocks the efflux. It blocks ABCG2 such that water is not taken out of the pool again. We saw this significantly increased exposure to SN-38 without altering the safety. Thereby, we expect stronger biological activity, which is what we see with our clinical data. What does it mean for our strategy? Well, we need to use this information to focus our strategy. It means that we will fully exploit the combination with irinotecan. That means that we are developing, as we found from our first study, a product which aims at treating metastatic colorectal cancer patients with wild-type RAS tumors. This is a clear segment. It also allows us to identify those patients. It gives a precision element and thereby de-risking the probability of success. We are optimizing the dose for that. That's what we have done in our study. What I just described to you with the lake and river picture is that there are two handles, two knobs you can turn on. One is SCO-101, the other one is irinotecan. We can do that combination so that it fits with the RAS wild-type patients, which is what we have done, but we can also adjust it so that we can reach in and do benefit for the RAS-mutated patients. That's what I've said a number of times on calls, that we haven't given up on the patients in metastatic colorectal cancer that has a tumor with a RAS mutation. It also allows us to do the same trick with other indications, thereby broadening the potential. Finally, we will use that also in combination with immune modulators or immune therapy to maximize the opportunity there. We shouldn't forget that we have a second trial where we are trying to learn. We just haven't reached the level of information yet. The combination with taxanes is potentially able to do exactly the same. PANTAX is ongoing, and I can promise you, do we see the same thing there, we will push the throttle on all the taxane areas. This also means that this is where our focus will be, and as I've said a couple of times, we are deprioritizing from other areas of combination at the moment simply because we don't have the information, we don't have the science, the mechanism of action, and that just wouldn't be wise from a probability of success perspective. This brings me to a key slide here. This is how will we develop SCO-101 all the way to the market. What you see here, you can compare to a double-shot espresso or a double-barrel gun. There are two shots on goal. That's what I'm saying here. We have CORIST part one, or the CORIST trial, there we've done CORIST part one. We have just engaged in CORIST part two, this will lead us up to a point where we will have proof of concept. This proof of concept is extremely important for a company like Scandion Oncology. In order to engage into a second line of therapy, we need to look what is being used in second line of therapy. There, standard of care is using antibodies against either EGFR or VEGF in the treatment. We had all the time planned to have the possibility for what was termed a part three. This was an expansion of part two in order to get the proof of concept. We will use that to guide a positioning study where we will add antibody to irinotecan and also FOLFIRI and SCO-101 in order to understand what is the right combination for a potential pivotal study which is outlined. Let me say that nothing has changed in terms of runway and funding at this point in time. The important thing is to understand at the end of here is an aim for market approval, but also the potential to go broader in a potential multi-blockbuster market for SCO-101 in combination with irinotecan. The second part I spoke to there is that we are also interested in finding the right combination that can tackle the problem for metastatic colorectal cancer patients with RAS-mutated tumors. This will mean that we will look at combinations with either FOLFIRI or irinotecan in order to get there. This is strategy. Finally, all the additional indications that I will speak more to. There's an added leg on this one, which says immuno-oncology. We see that as a major opportunity to explore based on the preclinical data that we have. It's also an area where we find it likely that this is an area where we could partner early. We are looking for doing that in a partnering context, and we think that this would be the right way to bring that forward. The second part or the second shot on goal is our PANTAX. We have PANTAX I-B. We are trailing and a readout in Q3, Q4 of this year. We have already set aside resources and plans for randomized control phase II. In that case, both of these studies could lead to initiation of pivotal trials in the range of 2023. The primary path that we are talking about here is really how do we get our metastatic colorectal cancer approval in RAS wild-type patients. This is based on insights, and here is a very large information on this slide. What you can see is that this is the way that the colorectal cancer treatment algorithm looks when you go through it. What we are aiming at is the segment of RAS wild-type patients, where in all the treatment lines you have antibody and FOLFIRI used as backbone. There are other alternatives, but we are obviously focused on the ones where we have FOLFIRI involved. For that reason, we are targeting a strategy where we will aim for a second line of therapy approval with FOLFIRI and with an antibody. If we look at the landscape here in terms of patients, this is the market that we would be looking for with patients in this segment. RAS wild-type metastatic colorectal cancer. All of these markets are expecting an increase in patients. Most dramatically, it's in China. There's a particular thing to China strategy, and this might also come from better diagnosis in that area. Both in EU, in Japan, and in U.S., the numbers are unfortunately expected to go up. First line of therapy is obviously the biggest majority of treatment. That's what you see first as a medical treatment for metastatic colorectal cancer. Second line of therapy is clearly a very large portion as well, and a very attractive entry point for a new therapy, which will also allow for third line of therapy. Obviously, going for where we are today would be the red segment, where we are with third line failures. We are moving our strategy in a direction that we can aim for a second line of therapy. To do that, we need to say, okay, that's great, but how are you going to do that? We have envisioned a target product profile, and all I can say is that we are looking at a product where SCO would be in combination with FOLFIRI, either with or without anti-VEGF or anti-VEGFR antibodies for metastatic colorectal cancers patients with RAS wild-type tumors. This is just important to say that you need to think what your product looks like before you set out on the journey in order to use your shareholders' money in the best fashion. The path to registration is really encapsulated in this slide for that journey. I've already said that we are in motion with CORIST Part 2, which is a phase II trial. This will give us a POC, hopefully, but it's planned for Q2, Q3 next year. We are adding an arm to this, which is already within our plans. It's funded that we call CORIST Part 3, which will allow us to test these combinations and aim for a second line so that we understand how will we dose, and how will we conduct our pivotal trial eventually. I think that it's important to say that this really significantly increases the market that we are aiming for by more than fivefold. It's also important to say that I promise that we could broaden the use of SCO-101 and irinotecan across indications. If we look at the irinotecan landscape, this is mainly being used for colorectal cancer. This was where it was approved. When you look at other indications, one that comes to mind is really pancreatic cancer, where we see an opportunity. There are also other cancers. One of them is mentioned here, gastroesophageal cancer, but also other cancers of the liver. I think that the other opportunity here is really to understand how do we bring in the 45% that have a RAS mutation, because this would complete the landscape. There we would work on, again, tuning the two knobs in terms of optimizing the combination of SCO-101 and irinotecan in that aspect. There are a number of novel irinotecan drugs coming out on the market. You can sort of segment them in two groups. There are liposomal formulations. The most well-known has a trade name ONIVYDE. There's a targeted SN-38 antibody called TRODELVY. Both of these have entered the market and been approved, and are expected to increase sales over the years. Both come with certain caveats in terms of toxicity profiles and so on, but they're being tested in other cancers than metastatic colorectal cancer, e.g., bladder cancer, small cell lung cancer, and breast cancer. What we think is that we have a better option than these, because in terms of these two products, they are fixed product. We have an add-on that we can fine-tune in combination with irinotecan, thereby utilize our unique ability to increase the exposure. This opens for the opportunities that we think SCO-101 can give in combinations with irinotecan in other indications. We will speak more to those data. You will see them, so hang on. Now, let me turn to the opportunity we see in immuno-oncology. When we look at immunotherapy in cancer therapy, this is a revolution, you can say. Imagine if we could attract the patient's own immune system and get it to attack the cancer. The concept is clear. There are billions of dollars invested into the concept. Unfortunately, efficacy has not really delivered on the promises as a general. The field is starting to utilize cytostatics and chemotherapy in an increasing fashion in order to increase the response. In simple terms, immunotherapy is great, but we think we can make it go from great to greater. This is really by adding irinotecan, SCO-101, together with an immunotherapy. This concept we're going to test, and we are going to make sure we have the data to support the right direction before we engage in any heavy investment into the area. We've already talked about Alligator. We have data in the company where we have substantiated the concept. This is an example of such a data set. Here, a mouse bearing a resistant tumor was subjected to immunotherapy, chemotherapy, and SCO-101. From my experience working with oncology discovery and cancer drug development for more than two decades, I've never seen a response where a mouse like this, a group of mice, became tumor-free, 90% of them, so 9 out of 10, became tumor-free after this combination that I just spoke to. This really gets the color in my cheeks up and gets the company focused on we need to find out how can we explore and exploit this more. The strategy here is to develop data, understand the potential here of combination of SCO-101 with chemotherapy and an immunotherapy in preclinical models in order to position it right, and then minimize the risk by combining SCO-101 with marketed immunotherapy. This means that we are taking probability of success out of one of the equations, because it's already there, marketed and approved, and then obtaining a strong proof of concept with that and pursuing co-development, partnerships, or other ways of strategically positioning this area. In terms of PANTAX, I briefly mentioned it. PANTAX is our study where we are actually aiming for a first-line therapy. We are combining SCO-101 with nab-paclitaxel and gemcitabine in either non-resectable or inoperable pancreatic cancers or metastatic pancreatic cancer. There, we are trailing a readout this year in the range of second half of this year. This will guide our decisions on how to continue this program vis-à-vis what we have done in CORIST. Hopefully, the data looks as strong, and then this will be our second shot on goal for a strategy towards a pivotal trial. In terms of securing all this, because we are talking about developing a medicine, we are talking about creating value, making it more visible, and quantifying the risk. Clearly, intellectual property is a factor. We have strong IP. We have just announced that the protection of combination of SCO-101 with anticancer agents was granted in the U.S. We have this in force at least until 2037, 2038. We also have a large and aggressive patent strategy, and we have a large patent estate that protects us in terms of other applications. The patent portfolio has currently four unpublished patent families, where we are extending protection up to 2042 or longer. This means we have a very strong IP foundation for the company. Taking you back to what the development to market looks like, let me reiterate that we have two shots on goal. We have what I would call a game-changing opportunity in immuno-oncology. Finally, we shouldn't forget that we are continuing to build value. What I'm depicting here is really in the same fashion as we've done with SCO-101, we will expand our pipeline based on science and data, mechanism for action. We will tackle other problems relative to changing the fate for this 90% of cancer patients that have to leave this world due to cancer drug resistance. With that said, I think for me, this has been a marvelous journey. I'm extremely excited, especially driven with the data. Let me just tell you why I think it's important that you invest in Scandion Oncology, and why I've done it myself. First of all, we are first movers in cancer drug resistance. We have a first-in-class therapy. We have strong IP, and we have a game-changing approach. There is a high medical need. I depicted it in a specific fashion, but the medical need is immense. There are 10 million cancer deaths on an annual basis. As an add-on to gold standard that has shown that it works, why shouldn't we re-potentiate that? SCO-101 has platform potential. I think we have de-risked this asset. In my view, we are near to proof of concept. This is an important value inflection point. We have two shots on goal for pivotal trials within reach of 2023. It's not that far away. We are a pivotal stage company. We have a good safety profile, and we have shown that the biological activity, and we will show that also later in this presentation, is present. We are also moving the company, and we have moved the company from a more broad-focused research approach to really saying, okay, what's your path to value creation? This means that we have focused our early-stage strategies. It means that we have mapped out, which I laid out today, a clear route to what a market approval could look like. We see a myriad, a plethora of opportunities in this area. I think that the leadership team, and that's not just the executive leadership team, but the whole team in the company, including the board of directors and the SAB that we have brought to bear with this company, really substantiates a strong industry-leading team with track records, with strong networks in the field, and with the will to make a difference for cancer patients. Let me just remind you, there are multiple value inflection points coming up. I spoke to them. We have the POC with our CORIST part 2 in Q2, Q3 of next year. We could see a pivotal trial initiation in 2023. It's not that far away. We have our pancreatic cancer readout from the phase I-B of PANTAX coming up in the second half of the year. At this point in time, I will just reiterate the key takeaways, because hopefully when I mentioned some of them the first time, you have stayed on to this presentation. If you take home something from here, it's really CORIST significantly increases our confidence in the mechanism of action. This is what we are building our strategy on, and this is what we're going to exploit. It just underpins the fact that SCO-101 is a first-in-class project. It has a unique ability to tweak mechanisms and can add value to existing gold standards. We have set out a high bar for ourselves, and we will continue to strive. We don't want to get into work to do just any other business. We want to transform lives for patients that suffer from cancer. We all have personal histories with patients that suffer from cancer. We aggressively will exploit SCO-101 and the ability to potentiate irinotecan, where we can say data drives our strategy to a sound market opportunity in an unprecedented fashion. Envision a game-changer. We will test that and hopefully find that this is correct. We envision a game-changer in immuno-oncology. That's a very attractive approach towards, you can say, the new kid on the block. Then let me just remind you that with all that vision, it's also important to stay grounded. We reaffirm our previously communicated timelines for our data, and we'll stick to that. Now, the presentation will continue with an interview with our recent addition to our clinical advisory board, Dr. Josep Tabernero. I already introduced Josep. He's a world-renowned key opinion leader, past president of ESMO, highly regarded in the area of gastrointestinal cancers. One commitment that I have made to Josep is that we have allowed making this exclusive for our shareholders and participants at the Capital Markets Day. For that reason, I'm bringing a disclaimer that unauthorized copying or alteration or distribution of this video is prohibited. This commitment I've made to Josep. With that said, I think we should continue with the interview with Josep, and I thank you very much for your attention so far. Thank you. Most interesting. Also thank you both for the presentation earlier. We're looking forward to hear more about CORIST and an update from Maj Hedtjärn, COO and Head of R&D. Floor is yours. Thank you very much. I want to start by saying it's really a pleasure for me to be here today, and I'm looking forward to giving you an update on our CORIST study. To start with, the CORIST study is a really important study for Scandion Oncology. It was the first clinical study that was initiated with the lead candidate SCO-101, and the first patient was dosed in May 2020. Now the study is divided in two different parts, part one and part two. In June we had positive interim readout from the first part of the study, and we have set a dose for the second part of the study, which has also been initiated now. About part one of the CORIST study, just to remind you about this and also if we have any new spectators. The patient population we are treating here are patients with metastatic colorectal cancer who have demonstrated acquired FOLFIRI resistance. This means that they have developed resistance against FOLFIRI, but also against other chemotherapy, and they are at a terminal stage of their disease with little hope for further treatment. This is what we have been looking at in the CORIST study. The key objectives of the first part were to establish a safe dose that could be given of SCO-101 in combination with FOLFIRI. What we did in this study was we had two different cohorts. In the first cohort, we dosed the patients with a fixed dose of SCO-101, and we gave varying doses of the chemotherapy. Here we had 12 patients. In the second cohort, we used a reduced dose of SCO-101 together with a fixed dose of the chemotherapy. What were the key learnings that we have? We met all the objectives of this study, and we found a safe dose for the next part of the study. That is, of course, really important. We have some important learnings that we want to share with you, and we want to tell a little bit more about this. One thing that has been mentioned a lot, and I will talk more about it again, is that we could see that SCO-101 in combination with FOLFIRI potentiated the biological activity of FOLFIRI or irinotecan, and that patient with RAS mutated tumors, they could tolerate higher doses of SCO-101 and FOLFIRI, and that they could stay longer on treatment compared to the RAS mutated patients. This means that our primary development strategy is to focus on metastatic colorectal cancer patients who have wild type RAS tumors, and where we build on the learnings from the CORIST part one. When we're talking about this potentiation of FOLFIRI, what do we actually mean by this? I'm coming back to this slide and going a bit more into detail. FOLFIRI, as mentioned, is a chemotherapy regimen, which is made up of three different drugs. The most important one that we focus on here when we talk about the potentiation is irinotecan which is a topoisomerase inhibitors. In irinotecan what you can see here in this cartoon is that irinotecan when it gets into the body, it will be metabolized into an active metabolite, which is called SN-38. SN-38 is the metabolite that will do the job. What we need it to do is that it should kill the cancer cells, and this is what SN-38 is doing. If you're treating a patient with irinotecan, here you can see what it looks like when you give irinotecan, only irinotecan. What you will see is that you will get a rapid increase in the amount of irinotecan in the patient's blood. You can also see that relatively quickly, the irinotecan, or actually the SN-38, the active metabolite, also it will decrease again, and it will disappear relatively rapidly out of the body. What does this mean? It's of course important that you have the SN-38 present as long time as possible in the body because the longer it's there, the more effect it can have on the cancer cells. What have we seen? When we pretreat the patients with SCO-101 before we give them FOLFIRI which contains irinotecan, what we observed in the CORIST study is the following. What you can see here is that you can have both more, you can see that the green peak is getting much higher than the gray peak for only irinotecan, and that it stays longer, it lasts longer compared to irinotecan alone. This means that we, with SCO-101, really can potentiate the effect of irinotecan and especially with SN-38. The important parts of this is that this means that SN-38, it will be available for a longer time in the patient so that it has a higher probability to actually get into the tumors and make an effect in there. What is important to say here is also that you could think that, yeah, why don't you just maybe give a higher dose of irinotecan? Wouldn't you see the same thing there? Well, actually, if you give a higher dose of irinotecan, it's been shown that this is giving relatively high toxicity to the patient, so you cannot do that. In our combination with SCO-101, not only do we see more SN-38 and for a longer time, but we also can see this with a very good safety profile. It means also that we can lower the dose of irinotecan to be given and get a better effect than you would get with irinotecan alone. We think this is really something that is pretty extraordinary. This is why we are so excited about the data from the CORIST study. This is really why we feel that this is something we want to build upon. To summarize, we have really documented a unique mechanism of action here. We have also filed a patent on these findings because we think this is very important and it's something that we want to protect. This gives us also an ability to expand the therapeutic index. You heard Josep Tabernero, he also talked about therapeutic index. This is very important when you're developing medicine. You want to have as much space as possible, you could say, between the dose where you're getting an effect of your drug and the dose where you see toxicity. The more you can expand that, the better it is. This is really why we believe that irinotecan together with SCO-101, it can form a basis for a new and improved treatment regimen in cancer. Next, we've also demonstrated that patients with RAS wild type mutated, with wild type tumors, they tolerated higher doses of SCO-101 and FOLFIRI, and that they stayed longer on treatment compared to the RAS mutated patients. First of all, the question is, what is RAS? We want to use it as a biomarker, but how can we do that? In approximately 45% of all patients with colorectal cancer, they have a mutation in the RAS gene. RAS is an oncogene, it means when you're having this mutation, that the cancer, it starts growing more uncontrolled, and it's kind of driving the growth of the tumor. The good thing you could say also with RAS is that actually as part of when patients come in and they are diagnosed for metastatic colorectal cancer, they will be screened for RAS mutations. You will early on, when the patients come in, you will know what is the RAS status, so it will be easy to select the patients for treatment when you only want to focus on the RAS wild type patients. This is a slide where we're showing you the time on trial for all the patients that were in CORIST part 1. Back in June, when we presented the interim results, you saw some of these data as part of the Kaplan-Meier plot, where you could see how it differentiated between the RAS mutated and the RAS wild type patients. Now you see the data in a different form. We can say that today we have one patient that is still on treatment in the study, and this patient is marked with an asterisk. It's a patient in the RAS wild type treatment group. What is clear from this picture, in the blue turquoise color, you can see all the patients that had a RAS mutation in their tumors. It's clearly to be seen that they didn't stay very long time on treatment, and actually none of these patients made it past the first status screen, which is after approximately eight weeks. When you're looking at the purple color, this represents the RAS wild type patients. You can see there that six out of the eight patients, they passed the first status screen, so it means they made it on into the study. You can see that five of these patients stayed on trial for more than 100 days. We have one patient that was on trial for 162 days, so it was up to the third status screen, and one patient has been on trial for 216 days. We really think, of course, this is a small set of data. We don't want to draw any conclusions, but we think this data is really very encouraging. When we're talking about the RAS mutated patients, because we say also that they didn't tolerate the treatment as well, and this is what you can see on this slide, that when you're looking at the different cohorts, you can see when you're looking at a mixed population of patients, you can see that in the first cohort at the 150 milligrams, that there was not such a good safety profile. In the second cohort with a reduced dose of SCO-101 and a reduced dose of chemo, we had a good safety profile. However, when you're looking at the patients with a wild-type RAS, they have a much cleaner safety profile, and in the first cohort, you can see here that this dosing, which we call level 3 of chemotherapy, and with SCO-101 at 150 mg, you can see that they have a very clean safety profile. Because we can see this difference between the RAS mutant and the RAS wild-type patients, this will be the dose that we are continuing with in part 2 of CORIST. It is 150 mg of SCO-101, and it's a reduced dose of FOLFIRI, a 50% reduction in dose, but this is the dose we've been able to show that we significantly increase the SN-38 exposure compared to a normal dose of irinotecan. We will use a RAS biomarker for patient selection for the second part of the study. The objective of part 2 of the study is to continuously look for safety and tolerability, but also to look for the objective response rate, so to look at the tumor and if there are any reductions in the tumor size in the patients. The secondary objectives, we will be looking for clinical benefit rate, progression-free survival, and overall survival, duration of response, and we will keep looking for clinical biomarkers to see if we can find additional biomarkers that can predict response of SCO in combination with FOLFIRI. Because of the change in patient population for part 2, we have amended the protocol that we had. We sent it in, it was approved now in the beginning of September, which is very good, and it means that we can start to include patients in the study. We have a plan to include 25 patients in this part 2, as mentioned, the dose that we will give is 150 mg of SCO with a reduced dose of FOLFIRI, RAS wild-type tumors. The timelines are that we expect to have a data readout in Q2 to Q3 2022. We are working on opening additional sites. It's important to us to see if we can increase recruitment rate even more. What I want to show you here is a slide of, first of all, you can see in Denmark, we are expanding to five Danish sites. We had two before. We are opening sites in Sønderborg, Hillerød, and Roskilde, and all the Danish sites will be open in September. Not only in Denmark, we are also expanding outside Denmark. It's important for us to internationalize the study. First of all, we are looking to expand it primarily in Europe. We are looking for Germany and Spain as potential countries. We also want to open sites in the U.S. Finally, the path to registration as we see it, and we have talked to it before, so it's important to mention the CORIST part 2 study. It's ongoing, and we have a planned POC approximately one year from now. The CORIST part 3, which is the part that was planned, it will be redesigned so that we can look at to better position SCO-101 for a pivotal study in the second line of treatment. We have these additional 10 patients, and it's important for us to recruit them as soon as possible. We are working on that, and we are planning to open an IND in 2021, 2022, so that we can start including patients also in the U.S. because the pivotal study that we are planning, that is going to run both in Europe and in the U.S. I want to stop by having a quote from Benny Vittrup, who is Head of the Pancreatic Cancer Center at Herlev University Hospital in Copenhagen, Denmark, that he's also seen the opportunities with SCO-101, and he says that, "In my opinion, SCO-101 with its dual action is one of the most exciting new opportunities in the development of new treatment options for patients with metastatic colorectal cancer in the past 15 years." With that, I want to stop my talk, and thank you so much for listening. Thank you, Maj. Very good run-through of the CORIST study and what to expect going forward. The next stage is Bo Rode Hansen again, and we're looking forward to hearing more about key events. Yes. Well, it's a pleasure to be back on stage and take this one step further. We are getting through the presentation here, and we just got a thorough, deep dive into why we think this is so exciting. This mechanism of action is unprecedented, and we are going to talk more to that in upcoming key events in the future. You will see us here today, you will see us there. I'm just going to tell you a bit about what we are expecting for the significant events coming up. Let me first reiterate. We have a readout on PANTAX. I already spoke to it several times. In this second half of this year, we're expecting to learn from our Phase I-B of PANTAX and use that to set the path forward for PANTAX's path towards pivotal, or in the same fashion as we've done with CORIST, making sure that we maximize probability of success. CORIST, Maj already mentioned it, is reading out one year from now with, I believe, strong proof of concept based on the mechanism that we've seen now, and we've set it up like that. Let me also remind you that our financial position secures us and our operations through to 2023. None of the things that we have spoken to today alters that situation. We have an event calendar, and in terms of where we will be present in the immediate future, these are some of the events. Right now, we are entertaining discussions at the LSX Nordic Congress. We will be present at the scientific conferences, AACR in NCI. EORTC is an important conference for the specific area that we are operating in. We also have our quarterly reports coming out, so the dates are stated here, and the year-end report. Besides from that, we will continuously update. We have plans for much more, so stay tuned and find this on our webpage and follow the company. Again, let me just remind you why I think it's so important to invest in Scandion Oncology also. At this point, we are first movers. We have a company here that are first movers in cancer drug resistance. We have a therapy that's targeting a very high unmet medical need. As Joe Biden said, Joe wants to cure cancer. Well, Joe, we are here to help you, and I think you need something that tackles cancer drug resistance if you really want to accomplish that mission, especially in your term. The de-risking of the clinical asset is something that I hope we portrayed today. I think it's very important to understand that we are on track with two shots on goal for pivotal trials. We will build our pipeline based on de-risking and proper proof of concept. That also means that we give you a clear path to what monetizing looks like, where the value lies, and in terms of broadening research, we will continue research, we will continue staying focused, and build the company from that basis. In terms of investing in us, you see the leadership team here, and we have multiple value inflection points coming up also in the coming months, years. Together, I invite you to join the journey building the cancer drug resistance company. With that said, I want to thank particularly the listeners, the spectators. I want to thank my team for really putting together midnight oil, staying in there, committed to the mission, getting up in the morning, all with the common vision of changing fate for cancer patients. With that said, I think we conclude the session, and we'll open for a Q&A. Shall we? Yes, welcome to the Q&A session, and please remind everybody to keep the questions short. Should be pretty obvious how you put them forward on the screen, and we can see what we have. First one is regarding the CORIST study. Favorable changes the adverse effect of chemotherapy. What does this mean? I think if I got the question right, it's what does it mean, favorable changes to the adverse effects? I think actually this question is really fair to pass it to Peter Michael, who has been seeing these patients or seeing patients all his life and can speak to that. Yes. What we've seen in the CORIST part 1 and also in part 2 trial is that we find that there are, especially the non-hematological toxicity, that is the part of the toxicity that does not have anything to do with the white blood cells or the platelets, that the amount of these side effects, the number of them seem to be fewer than we had expected. Interesting. Here's another always very relevant question. How are you expecting to finance the phase III, the pivotal study? Another question could, of course, be if you can expand what the structure, what to expect out of a pivotal study. Yeah. First part of that question is given. Biotech is a resource-intensive exercise. We are not net positive or revenue-creating enterprise, and funding is required. I think actually on the financial structure, I'll pass it to Johnny to speak to how do we see that we could build the financial structures for this. Certainly. Yes, as Bo said, any pivotal study, being Scandion or any other company, comes with a significant price tag. Funding, we will look into various potential means. One can be to fund it through equity, meaning capital raises. Another means is to do partnership deals, which is also something we are exploring. Finally, you can do various debt structures, and it can also be a combination of all three measures to fund a pivotal study. I can take another question. In the next coming up part of the CORIST study, primary endpoint is tumor and tissue shrinkage, what is the risk that it could be sort of a gray result, not crystal clear? I think that's obviously a fair question. It's not a binary game to do drug development. Everybody who's been in this business for long will know that. You're looking for clear results. What is the risk? The risk is obviously there, but I think what we have substantiated today, from my mind, is what really gets me confident that we have the best probability of success in the way we are doing this. Bear in mind the patients that we are treating in these trials, I don't think I'm stealing the words out of your mouth, Peter Michael, but these are patients that have seen a lot of therapy. They've been through all the therapy lines. They have progressed, meaning failed the therapy lines. They are patients that unfortunately do not have a very good prognosis outcome. Do you want to add to this? Well, I can say that when we do the status scans of these patients, we see two things. We see the shrinkage of the tumors, and we see if they can continue on the trial. Both these endpoints are important for our evaluation of how their effect of their CORIST and FOLFIRI treatment is. Yes, we saw from the presentation earlier, that we had some interesting results in these charts, of course. A related question, we saw that you, going forward and with the reduced FOLFIRI, is it also possible to change the interval? Do you want to address that? You mean the interval with the treatment? Yes how you give. Maybe we give it more often with a lower dose. This is what we've seen, the interesting thing with SCO and also with irinotecan, and what we can see is that we really believe that we can tweak the exposure curve of SN-38, so that there will be a different means of doing this. This is something that we also want to explore, for example, for the RAS mutated patients. We definitely believe that there are different ways to optimize things if that would be needed. Interesting. Another question is, of course, more or less half of this initial patient cohort target, you could double that if you can include RAS mutated patients as well. How complicated or difficult is it to optimize for this group? I think that it is important to say that this is why I keep saying we have two knobs to turn on here. This gives us opportunity to optimize, that is the reason why I also with confidence can say we have not given up on the RAS mutated patient population in terms of metastatic colorectal cancer. Would you add to how you would do it, or? Well, I think the very short answer to that is that we have the SCO-101, we have the chemotherapy, and we can turn up and turn down for both of these knobs, as Bo mentioned, and I think this is what we are going to have to do and will do when we explore the RAS mutated patients or the patients with RAS mutated tumors later on. Excellent. If we stick to that study, the next stage is 25 patients. Is that a challenge to recruit these patients? You are looking into expanding number of sites. Yeah. Should I? Yes. No, we don't think that it will be a challenge. The reason also why we're expanding the number of sites is, of course, that in the first part of the CORIST study, we will taking in all patients, so with both RAS wild type and RAS mutated. You could see, say, in a way now we can take in half of that patient population, but this is why we're expanding to many different sites, and we don't see any issues with being able to recruit to that amount that we want to. Very good. What about the PANTAX study that is also a bit bigger? Is that more of a challenge or are you confident? Recruitment rate of patients is to some degree always a challenge, and that's why we're mitigating it by going broad in terms of sites. We're doing that in PANTAX as well. Unfortunately, there's a lot of patients because in pancreatic cancer, the treatment options do not look very good, and that's also why we managed to move in with a combination with the first-line therapy. We expect to keep our timelines as we have communicated them. Good. Another one, have you compared your CORIST Part 1 disease progression data with any historical control group in this RAS wild-type population? Mm-hmm. I think Peter Michael, you can speak to this. I think we have to repeat a little that in their Part 1 of the study, it is not the efficacy of their treatment that is the center of our attention. What is the center of our attention is their toxicity, because that is what determines the dose that we are going to use here in Part 2 of the CORIST study. It will be here in Part 2 of the CORIST study, we'll get a more coherent data set about how long time they can stay on trial and how many patients who will have a response on the treatment. Let's take that up again when we have seen the end of Part II. Yes, that seems reasonable. Here is another area altogether. Will there be more data presented from the pre-clinical study with Alligator? In terms of the pre-clinical data, we will present pre-clinical data from our studies in a fashion that it does not risk our value creation. Going out presenting pre-clinical data might encourage the market, but might actually diminish the value because patent protection is very dependent on that you have not created prior art for yourself, or you have not created a situation where you cannot patent the data strongly. We will present, in general, pre-clinical data as we find it valuable and as we find it necessary, and I can guarantee you, we want to be as transparent as possible on all our pre-clinical data. My job is to secure shareholders' value, and IP protection is one of those integrals. Also earlier on in the presentation, you were pretty clear that in the IO area, immuno-oncology area, you perceive that it's plausible with a partner earlier on, and that maybe relates to that. Yes. Awesome. Well, it relates to that, and it's also general. I think that in particular in the immuno-oncology area, as I said, I would see value, I think we would see value in combining with something where you can say you have de-risked the asset completely by being a marketed product. In that sense, if we can establish a concept with an immunotherapy, chemotherapy, and SCO-101, I think that is a very stronghold and a good position for commercial partnership discussion, and they can take many shapes and forms. As Johnny just spoke to, like with our financial path, there are many ways to structure these things. I would see this as an area where we would look to have a strong partner early on in this endeavor. Interesting. That brings us to another question. Is there any ongoing discussions with any potential partner at the time? Well, what I can say is that we are active. We are active in R&D, we are active in our development, we are active in our financial planning, we are active in our business development, and I think that's how you run a successful biopharmaceutical, biotech business. As such, all of those cannons are firing. This is what I can say about our activities internally. Yes, including the IO area, have you got an opinion or view when it's a good time to secure a partner? Is that before the structure is set for the pivotal study or earlier or later? You can always discuss. I think what our perspective is that it's not just about proving that you can get a deal. Look at the things that I have been involved in or Johnny Stilou has been involved in or Maj has been involved in. We think that there's plenty of precedents there for showing that we know what happens on this side and on the other side of the table. The important thing here is securing maximum value for a path forward for the company, for the shareholders. For that reason. The right timing, the sweet spot for doing deals can always be discussed. Obviously as a biotech, if big money is on the table, we will obviously consider. Good. You are cleverly focusing on the first two ponies, and especially the first pony initially, but you have several others potential on the go. How difficult and how much complexity is it to activate the other, and what sort of studies would you need to be doing to expand the label? To expand the label of SCO-101? Yeah. I think as we have focused now on getting a clear path to market, I think it will be much easier to increase the appetite when you have strong proof of concepts, when you have a path to market. If you have a marketed product, you can position it in other registrational trials and so on. This is a very detailed question to a broad strategy. What I'm saying is, don't forget that there's a platform element here. Irinotecan together with SCO-101 can be optimized, and this gives access to a potential multi-blockbuster market drug here if we go into these different indications. You can look how some of the other irinotecan formulations are trying to position themselves in indications that are not traditionally irinotecan indications or FOLFIRI indications. I think that tells you the potential here. I think we have a much better alternative because we have this dual mechanism of action. We can, in that way, tailor the exposure that we will get of SN-38, the active metabolite. Yes, earlier on you were pretty clear, and the message is that there is the potential to follow and expand on appropriate areas, not only for irinotecan but also for taxanes. Yeah. Yeah. The second part of that is, what I find important is that we do the studies, we find out fast if we have a path forward there. With all development, if you can render fast whether you have a path forward or deviate from the path, so fail fast is important. In that regard, we need to understand, do we have the same thing with the taxanes? If we do, which I think at this point in time, we will put full throttle on that activity as well. That gives you the second multi-blockbuster potential in that area. Yes. That's the way we're building the business. To go back to the CORIST study, you have the strategy to bring in the second line with the part III part of the CORIST study rather early on. Clearly that needs to be done before considering any pivotal study. Does that bring any risk of delays or complexity to the head of the pivotal study? Yeah. This is why we are also opening additional sites so that we can make sure that we can get the patients in as soon as possible and really run this in parallel with part two. This is our plan. Good. Another question, looking at the data presented today, would you consider an unofficial proof of concept based on Simon's two-stage? Sorry. This is Simon's two-stage. It's a very technical term. I think we'll pass that to you, Peter Michael. The question was, I'll rephrase it, do we use Simon's two-stage to show the proof of concept part of the study? Yes, in some ways we do. We have two stages with 25 patients first and then 10 patients afterwards, but we redress a little the time when we activate these two parts. We have 35 patients altogether. This is a technical question, it's a technical answer. I think this is the best that I can answer that. Yeah. Do you find any specific effect based on the primary tumor location, left versus right side of the CORIST trial? This is far too early to say anything about that. Yeah. Time is flying. Maybe we have time for a few more questions. Is there anything more to be said about the financing round? Would you prefer to do sort of directed smaller funding going forward, or would you consider a bigger funding? To your question, you can say that, as mentioned, the pivotal study, when we get there, it comes with a significant price tag and funding requirement, as I just elaborated about. In the meantime. Just to emphasize again, we have currently a strong cash position, which will take us into early 2023. Having said that, to take us all the way to initiation of the pivotal study, additional funding will be needed. We currently have an authorization to issue shares under a rights issue, so that is a path we can certainly take. The preferred path for us would be to combine it with a directed issue. The purpose of a directed issue alongside the rights issue would be the ability to attract institutional, international investors, long-term investors, which can help build the company in the long term. As said, the preferred path is to structure it together with a rights issue in combination, meaning that the current shareholders would be able to buy shares at the exact same terms as given under the directed issue, and hence we can fund this interim period until the initiation of pivotal studies, and hopefully attract new institutional investors. Thank you. Several of you have a lot of experience from bigger companies and big pharma and very successful SME pharmas, biotech as well. Any interest and response from old colleagues? Well, first of all, I can say that we bring with the company, not just the people on stage here, but the people around the company, the board, the Clinical Advisory Board, and so on, a plethora of strong network in the field, academia, big pharma, large biotech. Obviously, we keep our network warm. As I've said before, we are active in all our business lines in Scandion Oncology. I think that I can't give you any specific feedback from any particular, but I'm just saying on a broad scale, we are well-represented in the community. Yes. Bo, as you mentioned, Johnny has only worked in places where he has been bought out. Is that what to be expected now as well? It would be great if I could predict the future. What I can predict is my own intention, and I think the entire team's intention of how to create success. For me, and I think the team, success requires two things. One measure of success is that we succeed in developing medicine that can help critically ill patients. That's one. The other one is to create significant value for our investors, shareholders. Now, the good thing is that those two success criteria come hand in hand. If we succeed with one, we succeed with the other. Yet to your question, you're right. In my past two companies, they were from that perspective successful, and that was recognized by big pharma. Any biotech company is up for sale. Everyone knows that. That was recognized, and yes, there were successful exits of those two companies. Again, what I can promise is that we are and will be working every day to create success, both for patient and shareholders. Thanks. That's a good end of the Q&A. Before handing over to Bo for the final remarks, I just want to add one myself. I think it's a very good way to have a high degree of transparency, and you're very clear about the strategy and what you want to achieve and what you want to focus on, and also when to expect this. I hope many investors and companies are listening to this because that's very important when you're still a relatively small and very promising company that need to handle both significant risk and also the commitment from the shareholders and the investors. Thank you. Thank you. I think let me first thank my team for participating here, and thank the audience for staying with us. I hope we gave you some clarity on this case. Scandion Oncology, the cancer drug resistance company, is shifting gears. We are now laying out a strategy for becoming a phase III company with two shots on goal for pivotal trials. We are doing that with confidence in strong signal from our mechanism of action, really altering the exposure of SN-38, the active metabolite of irinotecan, but also showing you how we are building the company forward. I really look forward to the journey together, and I look forward to continuing the dialogue. With that said, I think we can conclude for today, and I thank you for participating.
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