Welcome to the Scandion Oncology audiocast for teleconference Q1 2022. Throughout the call, all participants will be in listen-only mode, and afterwards there'll be a question and answer session. Today, I'm pleased to present CEO Bo Rode Hansen, CFO Johnny Stilou, and CMO Alfredo Zurlo. Please begin your meeting. Thank you, and good morning everyone, and welcome to our first quarter 2022 interim report investor call. As you just heard, my name is Bo Rode Hansen, and I'm the CEO and President of Scandion Oncology. With me today is our CFO, Johnny Stilou, and our newly appointed Chief Medical Officer, Alfredo Zurlo, who I'm very happy to welcome to the company and also to our executive management team. Alfredo will introduce himself, and Johnny and I will be updating you on the development and the financial results for the first quarter of 2022, as well as recent events. Overall, it's been a very good start to the year, with solid operations and continued execution of our strategy and implementation of our plans. We remain on track for readouts from our two clinical trials later this year. Following our presentation, we're also happy to address your questions. Again, welcome and thank you for your interest in Scandion, and then I'll ask for the next slide, please. Before we begin, let me just remind you that we will be making some forward-looking statements during this call, and that those are by nature subject to significant risk and uncertainties as described in the disclaimer here. Moving on to slide three for the agenda. In our call today, I will update you on the development in the first quarter of 2022 and recent events. I will then ask Alfredo to introduce himself before I will present our pipeline of clinical and pre-clinical programs. Johnny will provide a financial update, after which, we will talk about the expected upcoming milestone events and our external profiling activities, ending with a reminder of our core strengths as a company. Next slide, please. At Scandion, we discover and develop first-in-class medicines that are aimed at treating cancer, which is resistant to current treatment options. We are among the world's leaders in reverting the cancer's resistance against treatment, thus making the treatment work both better and longer, thereby potentially prolonging and improving the lives of patients who would otherwise have a risk of dying from their cancers. This will, of course, also improve the lives of the patients' relatives and dear ones. You can say globally, close to 10 million patients die every year from treatment-resistant cancers. To us, that is simply unacceptable. Help bringing this number down is really what motivates everyone at Scandion in going to work every day. We have both the experience and the expertise and the molecules to help solve this massive problem in cancer treatment. Our medicines are relevant in several different cancers. This gives us the potential to provide treatment to millions of people who today don't have effective treatment options. That makes both our medical and commercial potential significant. 2022 will be a landmark year for Scandion, as we hope and expect to take some significant steps towards realizing the potential I just spoke about. Please turn to slide five. As I mentioned in the beginning, the first quarter of 2022 has seen a successful continuation of the momentum we built up in 2021. Our team demonstrates solid operational execution of our strategy to grow and optimize both Scandion as a company and our pipeline of potential new medicines. On this slide, you can see a couple of concrete examples of this, with the appointment of Mads Kronborg as Head of External Communications at the beginning of the year, and our achievements in communicating data for our lead asset, SCO-101, and also running and expanding the CORIST trial. I'm very pleased to say that we follow our plans as laid out and communicated. Most importantly, of course, that our two clinical trials with SCO-101, the CORIST and the PANTAX, remain ongoing. We expect readouts from both trials within the previously announced timeframe, which is the second or third quarter of 2022. I mean, given that we are now halfway through the second quarter, we believe that readouts will most likely come in the third quarter. That is going according to the plan. We also plan to further enhance our capabilities within the clinical development. To this end, we were very excited to announce the appointment of Dr. Alfredo Zurlo as Chief Medical Officer and also as a member of our executive management, and we announced that last week. I will hand over to Alfredo in a second for him to introduce himself, but let me first say how important it is for Scandion to be able to attract such a capacity to take this critical role for the company and lead both the daily operations of the trials and planning of the future steps. Not only does Alfredo bring decades of experience, but also a huge international network that Scandion will benefit from immensely. With that, I will actually ask you, Alfredo, to introduce yourself to the audience. Let's get the next slide. Thank you, Bo, and to everyone listening for the opportunity to present myself. I will start by explaining my motivation for joining Scandion, which is, in my opinion, a very interesting company that could hold one or more solutions to one of the biggest problems in modern cancer therapy, the resistance to treatment, as Bo spoke about just before. From my experience, both as a doctor and from working with clinical development in the pharmaceutical and biotech industry, there is a huge need for new innovation in this space. Today, too many lives are lost because of a lack of effective treatment for many patients. Reversing cancer's resistance to treatment and making treatments work better and longer would potentially make a huge improvement in cancer treatment as such. To join a company that is leading in this field and with a very promising lead asset, SCO-101, is a tremendous opportunity for me. In terms of my personal experience, you can see the highlights on the slide. I have more than 20 years of experience in planning and conducting early and late-stage clinical programs in oncology. I'm looking forward to applying this both in the day-to-day operation of the CORIST and PANTAX trials, as well as in the longer-term strategic planning of the development. I'm very focused on ensuring that we optimize both the medical and commercial potential of our compounds, first and foremost, SCO-101. As you can see, I have experience from both big pharma and biotech. I'm hopeful this will be an advantage. For instance, in relation to potential partnerships and alliances that Scandion may enter. On a personal level, I can mention that I will be relocating from Rome to Copenhagen with my family, and I'm looking forward very much to be a part of Scandion's mission to reverse cancer drug resistance and make therapies work better and longer. With that, I hand back to Bo. Please turn to slide seven. Thanks, Alfredo. Again, let me just extend a warm welcome to you to Scandion. We are delighted to have you on the team. Now, this overview on slide seven of our pipeline reflects the huge potential we see in SCO-101 in multiple cancers and in combination with multiple therapies. CORIST is our most advanced trial, and is actually spearheading clinical development within cancer drug resistance globally. A positive readout from CORIST will provide clinical proof of concept. This trial is done in patients with metastatic colorectal cancer, but we are optimistic that if the molecule works here, it will also work in other indications and combinations. As you may remember, CORIST was expanded to Germany and Spain earlier in the year, and sites are active in all countries. As I just stated, readout of CORIST is expected in the second, most likely third quarter of this year. The positive data confirming the data we already have will allow us to start planning the pivotal development of the molecule, potentially starting in 2023. We continue to explore opportunities to potentially conduct pivotal development in one or more partnerships. PANTAX is a Phase Ib trial in patients with unresectable or metastatic pancreatic cancer. The study is designed to provide us with data on the optimal dosing of SCO-101 in combination with nab-paclitaxel and gemcitabine, which is first or in some cases actually second line of therapy in this hard-to-treat indication. Currently, we are escalating the dose of SCO-101 according to the plan, and we will continue to increase the dose until we reach the toxicity levels. The higher we can dose, the better. Of course, continued escalation will also prolong the time until we can finalize the study. It's inevitable. We expect a readout in the second or most likely the third quarter of the year, and the positive data will allow us to plan a clinical proof of concept trial for this indication. In both CORIST and PANTAX, we do biomarker identification to help us identify the patients for whom the treatment may be most efficient. This means that we can target or personalize the treatments, which is very important when developing cancer treatments today. Confirming the broad potential we see for SCO-101, we are also conducting preclinical studies in which we combine the compound with immunotherapies. As stated earlier, we have made a number of highly promising findings in this space, and we are eagerly pursuing these. From what we know today, SCO-101 might enhance immunotherapy in multiple cancers, which would of course be another significant opportunity for the company. Finally, we are also conducting the preclinical activities with our second molecule, SCO-201, in solid tumors. In conclusion, we have several opportunities to make a real difference for cancer patients that today don't have effective treatment options. With that, I will hand over to our CFO, Johnny Stilou, who will update you on the financials. Please go ahead, Johnny. Thank you, Bo, and please turn to slide nine. This slide sums up our financial results in the first quarter of 2022. These are in line with our expectations as we continue to execute on our investment plans and maintain good cost control. As a biotech company, we invest in our molecules and our people as reflected by our research and development and general administration cost lines. The research and development is up compared to the first quarter of 2021, driven by the advancement and increased patient recruitment for the CORIST and PANTAX trials, and we expect a continued increase in investments as the trials progress towards finalization. The increase in general admin cost compared to the first quarter of 2021 is a result of the buildup of our organization over the past 12 to 15 months, during which we have attracted a number of seasoned industry experts to Scandion. With the appointment of Alfredo Zurlo, we don't foresee more major appointments short term, and so you should expect general admin costs to plateau on the current level. Our cash position is strong, and we remain fully funded into 2023, as previously stated. This also provides flexibility when we think about potentially securing additional funding, both in terms of timing and capital sources. Please move to slide 10 for more details on our spend and cash position. The first quarter of 2022 saw a cash spend of DKK 16.4 million, which is up from the first quarter of 2021, as explained on the previous slide. We ended the quarter with a cash position of DKK 88 million, which again is allowing us to fund our operations into 2023. With that, I'll hand the word back to Bo. Thank you, Johnny, and let's turn to slide 11. As I said, 2022 will be a landmark year for Scandion, with two expected top-line readouts from our clinical trials actually giving us a double shot on at goal. As mentioned earlier, CORIST will hopefully provide the clinical proof of concept for SCO-101, confirming our preclinical findings in patients. The primary efficacy objective is assessment of response, that is tumor reduction. Secondary objectives include assessment of clinical benefits, like duration of stable disease, progression-free survival, overall survival, as well as the biomarker assessment and correlation to treatment tolerability and outcome. We are looking very much forward to receiving and analyzing the data and hopefully start planning the path forward with pivotal development in mind. PANTAX, as also mentioned, will hopefully provide us with data on the optimal dosing, paving the way to move into a phase II with a randomized control trial that could provide the clinical proof of concept for SCO-101 with yet another chemotherapy now in pancreatic cancer patients. Again, a very exciting year for us looking forward to both these readouts. Next slide, please. Further to developing our molecules and company, we continue to prioritize the profiling of Scandion through proactive communication with external stakeholders. Our journey towards delivering new treatment options for cancer patients require long-term focus and insights, and there will be many value inflection points along the way. These needs to be visible to stakeholders, and therefore communication is most important to us. To this end, we have been active participants on a number of conferences, and we will continue to be that going forward. We are looking forward to present at several both local, meaning Scandinavian, and international conferences in the coming months, as outlined here on the slide. Please turn to slide 13. In conclusion here, in total, Scandion had a solid start to 2022, and 2022 will be a landmark year for us. We will continue to execute on our strategy in 2022, during which we have at least two potentially huge value inflection points with the readouts from CORIST and PANTAX. We will continue to leverage our strengths as first movers in cancer drug resistance with both a significant medical and commercial potential tied to that. We have de-risked SCO-101, and our pipeline provides several opportunities to expand into different therapy combinations and different cancers. We have built a strong organization and seasoned leadership team, now with Alfredo Zurlo just as the latest addition to that. We are ready to further develop the company based on hopefully positive readouts of our clinical trials. With that, I conclude our presentation and thank you for your attention, and we are now ready to take some questions and back to the operator of this call. Thank you. If you wish to ask a question, please dial zero one on your telephone keypads now to enter the queue. Once your name has been announced, you can ask your question. If you find it's answered before it's your turn to speak, you can dial zero two to cancel. Once again, that's zero one to ask a question or zero two if you need to cancel. There'll be a brief pause now while we register your questions. Okay. Currently, there seems to be no questions from the phone lines at this time. Okay. Okay. We have received a few questions online, so we will start asking some of them. We have one question. Can you say a few words about the new BOD members? They seem impressive. Yes, absolutely. I think that adding to the list of good news here is the evolution of the composition of our Board of Directors with Alejandra Mørk and Keld Flintholm-Jørgensen and Martine van Vugt who were elected to our board at our AGM in April. As Scandion develops, so does the board of directors naturally. The three new members all bring highly relevant capabilities for where the company is right now and the phase that we are moving towards, and also experience related to the Scandion strategy. I just warmly welcome this evolution at the board level of Scandion. Thank you. We have another question. Do you think it's possible to reach the primary objectives in the CORIST trial? I think that at this point in time to speculate on the outcome of an ongoing trial is way too early. What I can say is that, as I just stated in the presentation, is that both our trials are in motion and progressing well, and we look forward to reporting data from both CORIST and PANTAX later in the year. Thank you. We have another question in relation to CORIST. Have the study sites in Germany and Spain started to treat patients? I mentioned also in my note or my address this morning that all our sites are active. Again, let me just repeat, both trials are progressing and recruiting patients. Thank you. Another question is, when can we hear more about immuno-oncology? Our R&D strategy in terms of today, I'm saying that we are excited about immuno-oncology. We see a potential here, and we look forward to update externally on our strategies for developing our pipeline in the future. Okay, thank you. Another question is, when can we expect to move to Stockholm main markets? Good question. As you of course all have seen, the annual report was prepared adopting IFRS, and that is one of the many requirements we need to meet to do an uplisting to the main market. It is definitely something we are working on preparing the company, but we have not yet taken the formal step of applying. Preparations are ongoing. Thank you. Another question here, can we expect data and the results of part three of CORIST here in Q2, Q3? We are expecting to deliver data in the expected timeframe on the clinical trials that we have reported to the market. Thank you. A question here is, how does the poor data from ORIC-101 affect the market? I mean, for obvious reasons, I'm not in a position to speculate on how the market sees things or what happens at other enterprises or other companies. What we are focused on is developing SCO-101. We have strong preclinical data, and we are looking to optimistically towards delivering data in the given timeframe from Scandion. Thank you. We have a question. When will the analysis from Edison be published? Yes. As you have seen, we have engaged Edison to take up an analysis of the company, and we expect their first analysis to be available shortly. Thank you. We have another question here. Are the new BOD and management allowed to buy shares now when the report is published? Yes. Our internal or insider policy states that there is a closed period four weeks prior to any financial report or release, including financial information. Following that, there is an open period, assuming of course that no one are considered insiders for any other reasons. Thank you. We have another question here. Is there any risk that we will see further delays in CORIST or PANTAX? Just to restate what I've already said a couple of times, both our clinical trials are in motion. We expect to deliver results within the given timeframe Q2, Q3, and then for the reasons that I already gave, likely to be Q3. Thank you. We have another question. When will you apply for IND? In terms of our development and our regulatory strategies, we are constantly developing the clinical strategy towards pivotal trials. In that context, we are considering the various steps that needs to be taken also in various geographical zones. Thank you. We have a question here to Alfredo. What was the cherry topping that made you go to Scandion Oncology as CMO? Or were there several reasons for your decision? Well, I worked since a few years as consultant for the oncology industry, mainly with biotech and pharma. When I've been approached for this position, I really like the approach the company has because, you know, there is a lot of going on now in immunotherapies, and there is a lot of me-too products like another checkpoint inhibitor coming to the market. Maybe we are losing a bit the sight that most patients will receive chemotherapy. Almost all these patients are receiving adjuvant treatment, but most of those who are receiving it for palliative treatment will have resistance. Will develop, you know, later resistance. I think that the approach is very innovative, and this has potential to have a first in class in a new treatment approach is certainly relevant and that I like it a lot. I also have to say that I like the Nordic country, so the opportunity to move into Copenhagen was also something that for me and my family was interesting. Thank you, Alfredo. With that, we have no further questions here. Okay. Thank you. With that, we conclude this interim call for our first quarter earnings. I want to thank everyone for the attention and back to the operator. Thank you. This now concludes the conference. Thank you all very much for attending. You may now disconnect your lines.
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