Good morning, and welcome to the Q1 2023 earnings call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key, followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and one on your telephone keypad. To withdraw your question, please press star and two. Please note, this event is being recorded. I would now like to turn the conference over to François Martelet, CEO. Please go ahead, sir. Thank you very much, good morning to everyone, welcome to our Q1 2023 interim report investor call. As you heard, my name is François Martelet. I'm the CEO of Scandion Oncology. With me today, we have our Chief Financial Officer, Johnny Stilou. Johnny and I will be updating you on the development and financial results for the first quarter of 2023, as well as recent events. We made indeed very good progress in the quarter with strong execution of our plans, progressing our clinical trials and taking the first steps of our strategy to enter acute myeloid leukemia, another cancer with a huge unmet medical need. I will speak about that in a minute or so. Following our presentation, Johnny and I are delighted to answer any questions you may have. Please be informed that to best address your questions, we ask you to state these verbally. It will not be possible to put questions forward in writing. If you have a question, please follow the operator's instructions and ask verbally. Please also note that you will have to dial into 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. This is a disclaimer slide that I don't need to go through. Next slide, please. Today's call, I will firstly update you on the development in the first quarter of 2023, then I will talk about AML, acute myeloid leukemia. I will mention the rationale for entering into this indication and our progress to date in the execution of it. Afterwards, I will give an overview of our clinical trials and pipeline before Johnny will talk about financials. After that, I will present the strategic priorities for 2023 and our expected upcoming milestones events, ending with a reminder of our core strengths as a company. Next slide, please. At Scandion, as you know, we are a fully integrated R&D company, which role is to discover and develop first-class innovative medicines, aiming at ultimately treating cancer, which is resistant to current treatment options. We could become a potential leader in reverting cancer drug resistance against treatments, therefore, making the treatment working better and longer, and also that means improving an extended life of patients who would otherwise have a higher risk of dying from their cancer. We know that globally, close to 10 million patients die every year from cancer resistance. Further, many small molecules do fail in clinical development, very often likely due to drug resistance. This is definitely a massive issue in oncology that has been, for the most part, ignored by pharmaceutical companies. At Scandion, we are a small team of very senior level executives who have both the expertise and have the technology internally to make significant changes in drug resistance. Please turn to the next slide. We've had a good start of the year, excuse me, with our highly competent team of employees continuing to execute our plans. As you may recall, we introduced AML as a new opportunity for us when we presented our annual report in March. I'm delighted to report that we are well underway with several elements of our AML strategy, aiming at generating a comprehensive preclinical data package in this particular indication. Meaning that we are on track to present this in the second half of the year, and I will elaborate on AML shortly. We also reached an important milestone in the first quarter by achieving the primary endpoint with the PANTAX phase Ib trial, looking at SCO-101 as a combination treatment in pancreatic cancer. This is a strong demonstration of our ability as a small company to conduct multicenter clinical trials aiming at tackling drug resistance in cancer, which is a key capability as a company for us. With the top-line results from PANTAX, we have achieved the first of the two expected data readouts this year. The second being from the ongoing part three of the CORIST trial, in which SCO-101 is studied as a combination treatment in metastatic colorectal cancer. CORIST is ongoing as planned with good momentum in patient recruitment, which is the most important thing in this quarter. Turning to slide six, please. Acute myeloid leukemia is indeed an interesting opportunity for Scandion Oncology, both from a scientific and a strategic standpoint. First of all, let me tell you that the unmet medical need in this particular indication is huge. AML has the highest mortality rate of all leukemias, and as you may know, this is a blood cancer. Relapse is a very serious issue occurring in around 50 patients or more that were initially responding to treatment. The five-year overall survival rate for patients relapsing after transplantation is less than 20%. The need for new and improved treatment is massive. SCO-101 could potentially meet that need. The relapse of AML is very often caused by drug resistance, and already there is a body of clinical evidence, scientific literature, that suggests that the resistance could be caused by a protein, ABCG2, that SCO-101 specifically inhibits. Initial preclinical data suppose that inhibition of ABCG2 enhance the effect of AML drugs in ABCG2 overexpressing cancer cells. As you may know, there is no other specific ABCG2 inhibitor in clinical development. Therefore, with SCO-101, we may have a unique opportunity to develop a new and improved treatment for AML and potentially other blood cancers that are similar to AML. From a strategic standpoint, the expansion into AML gives us another short on goal, therefore, de-risking the company. De-risking our company from a research and development perspective. Commercially, the AML market is forecasted to grow, especially through relapse treatment, and combination treatment is recognized as a significant opportunity as well. Next slide, please. In order to preclinically confirm our potential in AML, we have articulated a strategy with three synergistic tracks. The goal is to effectively build a comprehensive preclinical data package that will provide us with an understanding of our potential in AML and obviously some new ideas on how to best explore further. Combined, the three tracks will ensure a thorough exploration of SCO-101 potential in this indication from different experiments with different types of cells. We can say that we could come to a plethora of preclinical data, and that will provide us with a sound basis for decision making and design of a potential clinical development plan. We are currently engaged in discussions with key opinion leaders from a leading AML research university hospital in Italy about research collaboration. This will allow us to have access to fresh cancer cells from AML patients, which is a unique and very strong research opportunity. Furthermore, we have entered into an agreement with a renowned global contract research organization, with the initial experiments already underway. Our focus here is exploring both ABCG2 expression in prior preserved cells from AML patients, as well as investigating synergistic effects between SCO-101 and chemotherapy that are currently used to treat AML. Both of these external activities are supplemented with ongoing internal research to explore the synergy between SCO-101 and AML chemotherapy. We have already established the cell lines and model systems, and experiments are ongoing internally. Overall, we are implementing our plan for exploring and validating the potential of our lead compound in AML. We continue to expect that these preclinical initiatives will yield data during the second half of this year, providing therefore the basis for a clinical development plan. Let me tell you a few in a few words, the next steps potentially. The first part of clinical development is expected to be a phase Ib clinical trial to investigate the safety of SCO-101 in combination with chemotherapy used to treat AML and to establish an MTD, which means maximum tolerated dose. As the safety of SCO-101 in combination with chemotherapy, FOLFIRI and gemcitabine and paclitaxel, has been already demonstrated in clinical trials, we are confident that SCO-101 may also be safe to be combined with therapies used to treat AML. Moving to slide eight, please. We had success in clinical development with the completion of the dose finding in the PANTAX phase Ib trial, looking at SCO-101 as a combination treatment in pancreatic cancer. Achieving a primary endpoint is always positive. In this case, it is important both in terms of establishing the maximum tolerated dose of SCO-101 in this specific indication and combination, and in terms of supporting the overall profile of the compound, as well as to rate it in combination with different chemotherapies in patients that are relevant. The final results of this PANTAX trial will be available next year. We will carefully analyze this before deciding the next steps from a development perspective of SCO-101 in pancreatic cancer. Please turn to slide nine. This is the slide showing you our pipeline. We will continue to develop SCO-101 as a potential combination of treatment in metastatic colorectal cancer with the CORIST trial. The ongoing part three of this trial is designed to identify the optimal dosing and administration schedule in this setting. We will be also looking at signals of efficacy, obviously. Patient recruitment remains good, and we continue to expect top-line results during the second half of this year. As also mentioned earlier, we have decided to deprioritize the development of our second compound, SCO-201, at least for the time being, in order to free up some resources to be able to prioritize the activities in AML, and at the same time, to be within our agreed-upon budget. It means that the potential of SCO-201 is still there, obviously, and still is intact. Having said that, I will hand it over now to Johnny for an update on our financials. Thank you, François, and please turn to slide 11. On this slide, you can see our financial results for the first quarter of 2023. These are as expected as we follow our investment plans and are in good control of our costs. The quarter shows a net loss of DKK 9.3 million, compared to DKK 12.9 million in Q1 of last year. The decrease reflects the effect of our good cost control. We ended the quarter with a cash position of DKK 60 million, and we reiterate our guidance that ongoing activities are funded into 2024. Moving on to slide 12. As you can see on this slide, we maintain the strong financial position I mentioned, with cash on hand to fund ongoing activities into 2024. You can also see that our quarterly spend continues to decrease, reflecting the cost-saving initiatives we have implemented, along with the effect of headcount reductions executed in the second half of 2022. The financial impact of these savings will strengthen our financials going into 2024. I will now hand the word back to François. Thank you, Johnny. Let's now move to slide 13. This is a summary slide about our strategic priorities for 2023, 2024. Obviously, our clinical trials remain our top priority. We have successfully achieved the primary endpoint in PANTAX. The focus here is now the follow-up period. That meaning collecting and analyzing the full data package from a safety and efficacy perspective. Based on this analysis, we will then decide on any potential next step. CORIST, the immediate priority is to complete part three and present the top-line results in the second half of the year. We will also here let the data guide us to any potential future developments. That will be also the case for AML, for which we plan to have the preclinical data in the second half of the year to be released. From there, we expect to be able to articulate a strategy from a clinical development standpoint. Next slide, please. We entered 2023, sorry, expecting a number of milestone events reflecting our strategic priorities, and are happy that we have now achieved the first within the top-line results from PANTAX. We maintain the expected timelines for both CORIST and AML data. Moving to the next slide, please. In a nutshell, in summary, we had a good start of the year, we continue to execute relentless our strategy. We continue to pursue our potential to deliver new and better cancer treatment for patients who so desperately need them with SCO-101. With that, I conclude our presentation, thank you for your attention. We are now ready to take any question you may have. Again, please remember that you only state your questions verbally. Now back to the operator, please. We will now begin the question and answer session. To ask a question, you must press star then one on your telephone keypad. If you are using a speakerphone, please pick up the headset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star and two. The first question comes from Christian Binder from Redeye. Please go ahead. Thank you so much for taking my questions. First one, just so I understand it correctly, a potential phase Ib trial in AML, can you give any more guidance on when you might start that? I mean, given the preclinical data presentation in the second half of this year, could we see you start a trial in that indication next year? Yes, I would obviously wish so, you know, but it depends on the result of the preclinical package. Now, we, as you know, you know, from preclinical to clinical stage, it takes about, you know, well, 12 to 18 months. Obviously, as soon as we have some good data, we will immediately start the preparation for the phase I. Got it. Just the second one, you've obviously already mentioned it, but when it comes to AML and pancreatic cancer, both are obviously promising indications, but in a theoretical scenario where you would need to prioritize one, can you just elaborate on how you look at the potential in those two indications and how you might, depending on what data points you might choose to prioritize between the two? Yeah. I mean, obviously, it all depends on the type of data we will get. This will be the prioritization by itself. You know, I cannot speculate at the present time, you know, which of the two indication will give us better data, but this is the way it is. At the same time, you know, if we would get, and also with CORIST, you know, two set of positive data in two different indications, that could obviously enhance our value as a company and therefore enhance also our possibility to further fund the company, through a direct issue or a right issue or both, you know, obviously. Yes, it all depends on the kind of data we will get, the quality and the strength of it. All right, got it. That was all from my side. Thank you so much. You're welcome. Thank you. Again, if you have a question, please press star and one. Gentlemen, so far there are no more questions from the phone. All right. Okay. At this point in time, you know, I would like to thank our shareholders, all our stakeholders. I would like to thank our employees also for the commitment to an area that is not easy from a cancer perspective, a cancer research perspective. You know, drug resistance is something that if we are successful with it, will provide us and more importantly, our patients, a tremendous opportunity to have a better treatment. Thank you for all our stakeholders and back to you, operator now. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect your lines. Goodbye.
Loading workspace