Welcome to Scandion Oncology Q3 Report 2023. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. Now we'll hand the conference over to CEO, Francois Martelet, CFO, Johnny Stilou, and CMO, Lars Damstrup. Please go ahead. Thank you. Good morning, everyone, and welcome to our Q3 2023 interim report investor call. As you just heard, my name is Francois Martelet. I'm the CEO of Scandion Oncology. With me today is our newly appointed Chief Medical Officer, Dr. Lars Damstrup, and our Chief Financial Officer, Johnny Stilou. We will be updating you on the development and financial results for the third quarter of 2023, as well as recent events. Actually, we will focus our attention today on the very significant news we put out yesterday regarding the new and very positive data from the second part of the CORIST trial. We will take the opportunity to present this data to you in more details on this call. Regarding the third quarter, we continue to execute on our strategy and plans, and I will speak about this in more detail shortly. Following our presentation, and as usual, we will be happy to answer any questions you may have. Please, be informed that to best address your questions, we ask you to state this verbally. It will not be possible to put questions forward in writing, so if you have a question, please follow the operator's instructions and ask them verbally. Please note that you will have to dial in into the call to be able to ask a question. This cannot be done through the webcast. Again, welcome to all of you and thank you for your interest, in Scandion. Can I have the next slide, please? Before we begin, let me remind you that, we will be making, forward-looking statements during this call, and those are by nature subject to significant risks and uncertainties as described in our disclaimer here. So could we move to the next slide, please? So I will firstly update you on the development in the third quarter of 2023. Then I will introduce you to Lars Damstrup, who joined Scandion in September as our new Chief Medical Officer. Afterwards, we will be focusing on our top priority, the CORIST phase 2 trial, investigating our lead compound, SCO-101, as a combination treatment in metastatic colorectal cancer. Lars will speak about both the new data from part 2 of the trial and the progress of the ongoing part 3. After that, he will be providing an update on our research in acute myeloid leukemia, we call that AML. I will then summarize and show an overview of our pipeline before handing it over to Johnny for an update on our financials. And finally, we will be presenting our strategic priorities for the remaining part of 2023 and 2024, and expected upcoming milestones events, followed by a reminder of our core strengths as a biotech company. Next slide, please. So, as you know, for those of you who do not know Scandion much, we are an R&D-based company with a role is to discover and develop first-in-class innovative medicines, ultimately aiming at treating cancer, which is resistant to current treatment options. We may become, down the road, you know, one of the leaders in reverting cancer drug resistance against treatments, thus making the treatment working better and longer, thereby improving and extending the life of patients who would otherwise have a higher risk of dying from their cancer. Globally, close to 10 million patients die every year from resistant cancer. Many small molecules fail in clinical development, and very often it is due to drug resistance. This is a massive issue in oncology that has been, for the most part, ignored by so many pharmaceutical companies, and for many reasons, essentially linked to the fact that many clinical trials were failing to achieve the, any endpoints. At Scandion, we have, we are a very small team of very senior level executives who both have the expertise to help making significant changes in drug resistance. Our R&D efforts could be potentially relevant in several different cancers, and not only in colorectal cancer, but colorectal cancer is and remains our main focus. Please turn to slide, to the next slide, please. So we are very pleased with the development in the next quarter. Overall, we have continued to execute rather strongly on our strategy, and therefore, we have maintained a strong operational momentum. We were delighted to welcome Lars as our new CMO in September. We have very good news from CORIST, from the CORIST trial, both in terms of the new data, part two, communicated yesterday and the progress of the ongoing part three, keeping us on track for top-line results before the end of the year. Today, we will be also presenting additional information on CORIST 2 on top of the PR presented yesterday, like the Kaplan-Meier curves. And last, we'll go into details in this with this. Our preclinical exploration of SCO-101 potential in AML has now been concluded. We will explain why we are not, we will not be pursuing this opportunity any further, and then Johnny will, as usual, update us on our finances. Next slide, please. So I am personally thrilled to have Lars Damstrup joining Scandion as our new Chief Medical Officer to lead the important work of planning and executing our clinical development with SCO-101. Lars and I worked at TopoTarget, unfortunately, about 10 years ago, and I'm really delighted to have him with us again. For the Danish listener today, at TopoTarget, TopoTarget was a Danish-based company. We brought together and others, but we brought belinostat, an HDAC inhibitor, to a successful registration path in the U.S. With his early clinical development expertise, Lars is extremely qualified to ensure the completion of our ongoing part three of CORIST, and of course, to plan for the next steps. He's a medical doctor with a Ph.D., with decades of experience in the development of new cancer treatments, both within the biotech sector and in the pharma world as well. He's actually a very strong addition to our management team. Having said that, I will now give the word to Lars to update you on CORIST. Next slide, please. First of all, thank you, Francois, and thank you for all of you listening in and listening to me for the first time. As Francois mentioned in the beginning, we have new and very interesting and positive data from the CORIST part 2 trial. As you can see on this slide, CORIST part 2 is part of our advanced development program, and as such, is a most important activity. It's a phase 2 trial studying SCO-101 as a treatment of patients with metastatic colorectal cancer in combination with FOLFIRI. FOLFIRI is a standard care in this patient population. Our belief is that SCO-101 can help patients who have a resistance to FOLFIRI to overcome this resistance, making it a very good combination partner and the treatment will work better and longer. CORIST consists of different parts conducted sequentially, and what we're talking about is part two, which enrolled 25 patients with metastatic colorectal cancer. All these patients were heavily pre-treated, which is very, very important. Patients received the SCO-101 for six days at a dose of 150 milligrams, and FOLFIRI was also given during this treatment combination. We already previously, in September 2022, reported the top-line results from this trial. Now, the new data we have now was communicated yesterday in a press release, and I'll elaborate on this. We are very encouraged by these data, which first and foremost shows impressive results in terms of overall survival, which of course is a very, very important parameter, outcome, parameter in patients with malignant diseases, because this is also a parameter which is established by both FDA and EMA as a regulatory endpoint. Now, from this slide, you can see that patients, and this is all the 25 patients that were enrolled in CORIST part two, had a median overall survival of 10.4 months, whereas a subset, this is not on this slide. We also had a... I'll come back to this, about the, this, potential biomarker. So at the end of the day, we have shown that the total population, compared to historical outcome, is quite impressive for the entire patient population. We know this, of course, this is only for 25 patients. And then, what's also important is that 7 patients are still alive even now, past 15 months of the initiation of treatment, which means that some of these, all these 7 patients will have an extended survival benefit. Next slide, please. What we also looked at is what is known as clinical benefit, clinical benefit ratio or rate, which is a combination of patients who have CR, complete remission, partial remission, and stable disease, which is also a very important parameter. And we can see that we have a clinical benefit ratio-... of 42% after 8 weeks and about 21% after 16 weeks. This is very encouraging from a point of view that, patients in this very hard to treat, last line therapy, would have this type of response. So we, as we conclude that these findings, both the overall survival, clinical benefit rate, supports that, our belief that SCO-101 has great potential in treating patients with, metastatic colorectal cancer. And the next slide, please. Now, we have also in the conduct of CORIST 1, 2, and also now in 3, but potentially best established so far in CORIST 1 and 2, have looked at the Bilirubin Index as a potential biomarker. This has further increased our strength and belief that the, that CORIST is, or that the SCO-101 is a valid, very valid, good product to be combined with FOLFIRI in patients with various diseases. Now, one of the things is that the SCO-101 will affect the level of unconjugated bilirubin in the blood. Some patients in our study will have a transient increase, and others will have a permanent increase. What does this mean? What? That means that we pre-treatment, which we evaluate the bilirubin, and also on day 7 and day 12, and we can categorize patients who have a transient, it goes up and then it falls back down, or it goes up and stays up. On this, we can subsegment our patient population into two groups. With that, next slide, please. This is exemplified on this graph here, only for as a biomarker for overall survival. You can see that the solid line is patients with a transient bilirubin increase, and the dotted line for those patients who have a permanent increase in bilirubin. It's quite impressive that we can subsegment or subdivide these patients, even though it's only for 25 patients. The p-value for this difference in overall survival, those which is 8 months versus 13.4 months, it's so impressive that the p-value is 0.001, and this has been tested by our external biostatistician, and these data are extremely robust. Next slide, please. So in conclusion, we have a number of positive findings from CORIST part 2, which was shown, which is shown on, on this slide. This creates a strong optimism for the continued development of SCO-101, and the ongoing part 3 of this trial. With this positive data, we are encouraged, and further clinical development of SCO-101 in combination with FOLFIRI in colorectal cancer is clearly warranted. And the next slide, please. Now, with respect to part 3 of CORIST, shortly after we completed CORIST 2, we initiated part 3, maintaining the momentum of the recruitment of patients into the CORIST. And we have sites in Denmark, Germany, and Spain, enrolling patients. We are very happy to, and proud to say that already now, a little more than a year later, we is from the initiation of part three of the CORIST trial, we have completed the recruitment of 25 patients. This is a testament both to Scandion experience in trial execution, but also interest from the in the trial from treatment decisions, as well as this high unmet medical need in this indication. The fast way the trial is being conducted is even more impressive, given that we during this conduct of this trial, we also did an amendment, which also takes a lot, takes some time. So despite having an amendment done underway, we still did the completion within 12 months. Now, with the patient enrollment completed, we remain on track to obtain and communicate top-line results before the end of the year. As you may remember, this ongoing part three of the CORIST trial is a dose-finding study, in which we escalate the dose of SCO-101, looking for optimal dose and signs of efficacy. We are encouraged already now that we do see some efficacy trials, but I cannot come into this in more detail at this point in time. The next slide, please. Now, as you all know, we have also looked at AML in parallel with our clinical development. So we have been looking at SCO-101 in other indications, and our aim is to maximize both the medical and commercial potential of SCO-101, which we believe could be an effective combination treatment for several different cancers. To this end, we initiated some time ago a thorough investigation of SCO in combination in the preclinical models for AML. And we did this both internally and externally, which started in the beginning of this year. While our external studies in cellular model systems were successful of the relevant target in AML from cells from patients, we could not have this collaborate externally. Sorry, we had successful external data, but this could not be collaborated when we worked with an internal CRO. So therefore, we have now, at this point in time, decided not to pursue the opportunity of AML anymore. And with this, I hand over to Francois. And next slide, please. Thank you, Lars. So this slide number 14 will give you an overview of our pipeline of research and development programs. Further to CORIST, we have also conducted another clinical trial, PANTAX, in late stage pancreatic cancer, for which top line results were communicated in March of this year. The primary endpoint was met in this phase 1b trial, looking at SCO-101 in combination treatment in pancreatic cancer. We, by the way, plan to present the full analysis of the PANTAX data in the first half of next year. And this data will obviously help us to plan for future potential development in pancreatic cancer and or in other indications as well. Having said that, I will now hand over to Johnny for an update on our financials. Johnny, please. Thank you, François. Please turn to the next slide. On this slide, you can see our financial results for the third quarter and the first nine months of 2023. We are pleased to report a significant reduction in cost, both as a result of cost-saving measures and less cost in clinical development, as PANTAX is coming to closure. The development in cost reflects how we continuously exercise strict cost control and look for ways to limit our spending without jeopardizing the investments necessary for long-term value creation. Lowering our running cost prolongs our funding runway, which now extends into 2025. Moving to the next slide. By the end of the third quarter of 2023, we had a cash position of DKK 36 million. As just mentioned, this cash will fund the company into 2025. Still, we have taken the first steps to explore opportunities for expanding our financial runway to progress our programs. We will consider a number of sources, including partnerships and/or licensing deals, debts, grants, and share issues. Please note that we expect a continued decline in cost as the effects of the cost reductions implemented are incurred. With that, I will hand the word back to Francois. Thank you, Johnny. So we are now on the slide 18, which lists our priorities for the remaining part of the year, as well as 2024. Our connected development programs remains obviously our top priority. For CORIST, the immediate priority is to complete part 3 and present the top line data before the end of the year. For PANTAX, the next step is to conduct the full analysis of the data, and here also decide what could be the next steps. Finally, we always look for new indication area on the preclinical side, for which there is a reasonable chance of success that we can improve down the road treatment and therefore make a difference for patients. Next slide, please. So reflecting on our strategic priorities, as you can see from this slide, we have still several milestone events coming up in the next 12 months, and in particular, still before year-end. As you can see from this slide, you have let me repeat myself just a little bit. You know, the CORIST part analysis, the top-line data of the part three preclinical new indication, potentially. And we have also a press release on intellectual property, which will be looking at composition of the matter patent, covering the commercial form of SCO-101, extending our exclusivity to at least 2042. And that will be also obviously very important from a potential perspective with new indications. Moving on onto the next slide. So in conclusion, we had a good third quarter, maintaining our operational momentum. We continue to rely on our core strengths. We continue to execute our plan to pursue our potential to long term, to deliver new and better cancer treatment for the patients who are so desperately need them with SCO-101. Having said that, I will now conclude this presentation. I thank you for your attention. We are now ready to take any questions you may have. And again, please remember that you can only state your questions verbally. Back now to the operator, please. If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad…. The first question comes from the line of Christian Binder from Redeye. Please go ahead. Your line is open. Hi, and thank you so much for taking my questions. I have two. The first one, in your Q2 report, you remarked that your funding runway lasts into the second half of 2024, now it's 2025. Can you elaborate a little bit more on, does that purely derive from you not proceeding in, AML? And does it also include, CORIST part four? So, hi, Christian. Yes, we certainly can. It's correct that we now extend our runway into 2025. All the costs related to current ongoing programs are included in that cash forecast. That includes also the ongoing part 3 of the CORIST study. To your question about part 4, no, the part 4 of the CORIST study is not included in our cash forecast. The extension that we have from now from 2024 into 2025 is, as mentioned, derived from a continuous cost focus and reductions that we have done throughout the year. Again, reductions done without jeopardizing our investments needed for a long-term value creation. All right, got it. That was very helpful. And then another question regarding the CORIST part two data that you released yesterday. It seemed like the potential tumor reductions that you observed, they didn't meet the threshold for an objective response, and PFS didn't seem to be that different from historical controls. Would you say that these data may indicate that PFS and OR aren't really good proxies for overall survival in this setting? Or do you still think they might be useful readouts in future trials? Christian, this is Lars. I can reply to this. With respect to progression-free survival of an order of about 2 months, this is in line with last line therapy or for many other drugs. So the issue here is that we do see a very good overall survival benefit. And the issue, and also the relationship between overall survival and progression-free survival in many other trials with 600, 700, or 800 patients, there is a statistically significant progression-free survival, which could be from 1.8-2 months. But because of the numbers, this becomes statistically significant. We have 25 patients, so even though we have the same differences between the transient and the persistent, this does not reach statistical significance. What is more important, and this is what the take-home message is, we have an extremely high significance with respect to overall survival. All right, perfect. Got it. That was all from my side. Thank you so much. Okay, thank you. The next question comes from the line of Magnus Bernet from Direkt News. Please go ahead. Your line is open. Yes, hello. A couple of questions. Does the biomarker data that has been observed enable further studies in niche segments of the disease? Could you elaborate on what this means for the company in this regard? I still guess that you want to find a partner for SCO-101 rather sooner than later. What does this new data mean in terms of interest from potential partners? First of all, this is again Lars. I do not know what it means for an investor, investors, but certainly I would say this is a very, very strong selling argument, and therefore, what's the next step? This hypothesis would need to be tested in a randomized clinical trial. This is all I can say about this. You still there, Magnus? Yes, thank you. Okay, there are no more questions at this time. So as a reminder, if you wish to ask a question, please dial star five on your telephone keypad. We'll have a brief pause to see if there are any more questions. Seems to be no more questions at this time, so I hand the word back to you, Francois. Thank you, operator. This now concludes our conference call. Thank you all for attending this presentation that is extremely important for Scandion, and thank you for your interest as well. You may now disconnect your lines. Thank you. Bye now. Thanks. Bye.