Welcome to Scandion Oncology Q4 Report 2023. During the questions and answers session, participants are able to ask questions by dialing star five on the telephone keypad. Now we'll hand the conference over to CEO François Martelet and CFO Johnny Stilou. Please go ahead. Thank you very much, and good morning to everyone. Welcome to our Q4 year-end report for 2023. As you heard, my name is François Martelet. I'm the CEO of Scandion Oncology. With me today is our Chief Financial Officer, Johnny Stilou. We will be updating you on the development and financial results from the Q4 of 2023, as well as recent events as well. Following our presentation, we will be pleased 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 instruction and ask verbally. Please note that you will have to dial in to the call to be able to ask a question. This cannot be done through the webcast. Again, welcome, and thank you for your interest in Scandion. Next slide, please. So before we begin this presentation, let me remind you that we will be making forward-looking statements during the call. And those are, by nature, subject to significant risks and uncertainties, as described in our disclaimer here. Next slide, please. So in today's call, I will go through the pipeline, and I will continue with a reminder about the mechanism of action that we believe it's an important aspect of this presentation as well. Then I will go through our results so far with CORIST Part 3. Our CFO will address financial matters. Then I will conclude the presentation with a summary slides. Next slide, please. So as you know, we are an R&D company whose role is to discover, to develop first-in-class innovative medicines, ultimately aiming at treating cancer which is resistant to current treatment options. We may become down the road a leader in reverting cancer drug resistance against treatment, therefore making the treatment working better, longer, therefore improving and extending the life of patients who would otherwise have a higher risk of dying from the cancer. As you can see from this slide, this is our pipeline. So we have, as you know very well, at least for most of you, we have our main compound SCO-101, which is, studied in two different indications, colorectal cancer and pancreatic cancer. With regard to colorectal cancer, we actually ended 2023 on a high note with a very positive top-line result from Part 3 of the CORIST-2, phase II CORIST, trial for the treatment of drug-resistant metastatic colorectal cancer, and that was released in January, of this year. The Part 3 top-line results add to the positive data from the first two parts of the trial that we call CORIST Part 1 and Part 2, and therefore substantiate our biomodulating mechanism of action of our lead compound, SCO-101, through our ABCG2 and UGT1A1 targets. Then on the pancreatic side, we will be releasing the final data during H1 of this year, the final analysis of this phase Ib clinical trial using SCO-101 and Pexa-Vec oncolytic virus. And then we, most of you know as well, we have released preclinical data in gastric positive data with our SCO-101. We have put on hold our preclinical development of SCO-201, essentially for resource constraints. Next slide, please. So this is an important slide. So allow me, please, to spend one minute to remind you what is our mechanism of action. We are in the field of efflux pump inhibition. We are one of the very few companies in this innovative area. Furthermore, we are the only company in oncology in the efflux pump inhibition area. SCO-101 is, therefore, a targeted therapy in oncology. Our SCO-101 is a biomodulating agent targeting specific targets, ABCG2 and UGT1A1, on the surface of the cell for ABCG2 and for in the plasma for UGT1A1. The net effect of this mechanism of action is an increase of the efficacy of chemotherapy inside the cell. And of course, we do have clinical data, as I just mentioned, earlier, in colorectal cancer that validate this unique mechanism of action. Next slide, please. Right. So this is our most important slide of this presentation. So I will spend some time to go through it, quite carefully. So the top-line result from CORIST Part 3 confirms that the treatment is safe and well tolerated, while it also showed a number of encouraging signs of efficacy. An impressive tumor reduction of more than 30%, what we call partial response, was observed in one patient out of 21 evaluated. The median progression-free survival was 4.6 months, and that was superior to the PFS, progression-free survival, reported in CORIST Part 2. And the clinical benefit rate was 76% after eight weeks of treatment, a clear and very straightforward increase from the 46% CBR, clinical benefit rate, from CORIST Part 2. The optimal dosing schedule and maximum targeted dose, what we call MTD, was established for the six-day schedule. We are very encouraged by these results, not least being able to demonstrate impressive PFS for the participating patients and tumor shrinkage in a number of them. These results strongly support the potential of SCO-101 as a combination treatment in last-line colorectal cancer patients, a disease that we know is today very much characterized by high mortality rates and massive problems due to drug resistance. Now, you are all asking, you know, yourselves, what is the next step? So given the positive data collected so far during the CORIST trial, we are convinced we must push forward with the clinical development. With that in mind, we have assembled a strong advisory board with six internationally renowned key opinion leaders in December to support and guide us regarding our next steps in the clinical development in metastatic colorectal cancer, and I and I say again, last-line patients. Together with our advisors, we have agreed the first step to advance CORIST, the two-arm randomized phase IIb clinical trial, which with the optimal dose of, the cancer of SCO-101 and with irinotecan in combination with SCO-101. The goal is to establish the maximum targeted dose of SCO-101 at 250 milligrams with an increasing dose of irinotecan. Up to 12 patients in this small CORIST Part 3 testing will be divided into two groups. Once this is completed, Scandion will be fully ready for a randomized phase IIb/III clinical trial, a move that will put us in a strong market position. Next slide, please. Actually, this is for Johnny to address some of the comments with regard to financing. Thank you, François. Please turn to slide seven. On this slide, you can see our financial results for the Q4 and year-end results. The annual report itself will be published on 15 March 2024. We are pleased to report results both in the quarter and for the full year, which are in line with our expectations. Again, we see a significant reduction in cost in line with previous quarters. The full-year result is incurred with a loss of DKK 39.2 million, which is a significant improvement compared to a loss of DKK 76.7 million in 2022. Moving on to slide eight. We ended the year with a cash position of DKK 26.5 million, which, as previously mentioned, will fund the company and our operations into 2025. We see that cost throughout the year has reached a new and significantly lower plateau. We expect further cost reductions in 2024 as the full effect of previously initiated savings will be fully incurred. With that, I will hand the word back to François. Thank you very much, Johnny. Let's move to the next slide, please. This slide shows you our news flow for the whole year. As mentioned before, we have released earlier in the Q1 the CORIST Part 3 top-line data. We will be releasing during the first semester the CORIST Part 3, the PK study and safety data. And also, I said before, there will be a release of the Phase Ib final results for PANTAX. And then, you know, during the course of H2 of this year, we will be releasing the final data for CORIST Part 3. Something important to remember is that, you know, we continue to monitor our patients who have been enrolled in CORIST Part 3 to see whether the clinical benefit rate that, as most of you know, you know, it does include complete response, partial response, and stable disease, whether all those elements, you know, can be improved. And we will be certainly reminding and releasing press releases as much as we can and as long as we get some positive data. Next slide, please. So this is a summary slide of our core strengths as a company. Let me emphasize and point out a few things. So business development activities and partner discussions are highly prioritized and are part of our strategy to move forward. We have established contacts, and discussions are ongoing with potential partners, and we do expect the interest will continue to increase as we advance SCO-101 in clinical development. We have received very valuable and supportive feedback, and now we have a clear view on what the market and potential partners need. Drug resistance remains a massive problem in cancer treatment and in the development of new treatments. And if, you know, at Scandion, we can fulfill that mission of reverting drug resistance, therefore making treatments working better and longer, the benefits could be certainly game-changing for patients, relatives, healthcare professionals, and above all, the society. As I said before, Scandion is one of the very few oncology companies with a chance of providing these benefits through new innovative treatments and with this mechanism of action, efflux drug pump inhibition. We want to improve the fate of patients using the FOLFIRI cancer because of resistance towards current conventional chemotherapy. It's a pleasure for me to lead this work with our small team here in Copenhagen. We do have a strong belief in our compounds. We have a very clear business and development strategy. The management team is robust. We have a good board and advisory board to help ensure that we execute properly on time. So therefore, I feel very confident for 2024 and beyond. And this will conclude our presentation today. And therefore, I will give the word back to the operator for a Q&A. If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. The first question's from Christian Binder from Redeye. Please go ahead. Your line is open. Hi, and thanks so much for taking my questions, too, if that's possible. The first one, regarding, can you elaborate a little bit more on the timing around CORIST Part 3 extension cohorts? And then once you concluded those, how much time do you think will elapse until you can start your planned, phase IIb trial? Right. So obviously, we are working on finalizing this, the design of the clinical trial, which is an extension of the CORIST Part 3. We are also looking at alternatives from a financial perspective in order to finance this extension. Timing-wise, I cannot provide any firm timing on this. This is a matter of high priority on us, and we should be able to complete that as soon as possible, basically. All right. Great. And then regarding partnering, you already mentioned it during the presentation, but it seems like, both on the partnering and the financing side markets have been, falling a little bit in early 2024, from your perspective, do you think a potential partnership would be most likely before initiating your phase IIb trial, or do you think, afterwards it will be more likely given that you, hopefully will have stronger randomized data, so to speak? Right. Thank you for the question, which is actually a good one. Well, I mean, I cannot obviously provide you with some, since that's a public company, you know, some details about that. But be sure that this is high on our priority list, and we are working actively and extensively on that matter. And then, you know, once I will be able to share some news, I will certainly do it as well. Perfect. That was all from my side. Thank you so much. You're welcome. Yeah. There are no more questions from the telco, so I'll hand the word back to you, François and Johnny. Yeah, thank you very much for the patience for your patients, you investors, and, and shareholders. And we look forward to a very successful 2024. And, having said that, you know, I wish you a very good day. Thank you. This concludes today's call. You may disconnect your lines.
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