Good morning, and welcome to the Q2 2022 earnings conference call of Scandion Oncology. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event has been recorded. I would now like to turn the conference over to Mr. Bo Rode Hansen, Chief Executive Officer of Scandion Oncology. Please go ahead, sir. Thank you, and good morning, everyone, and welcome to our second quarter of 2022 interim report investor call. As you heard, my name is Bo Rode Hansen, and I'm the CEO and President of Scandion Oncology. With me today is our Chief Financial Officer, Johnny Stilou. Johnny and I will be updating you on the development and financial results for the second quarter of 2022, as well as recent events in the company. We are very happy with our achievements in the quarter. First and foremost, raising capital to enhance our financial position. I'm also glad to report that we continue our strong operational execution and progress in our clinical trials. Following our presentation, Johnny and I are happy to take your questions. Please be informed that in order to best address your questions, we ask you to state these 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 verbally. Again, welcome and thank you for your interest in Scandion. Next slide, please. Before we begin, let me just remind you that we will be making forward-looking statements during this call and that those are by nature subject to significant risks and uncertainties as described in our disclaimer here. Moving on to slide three for the agenda for this call. In our call today, I will update you on the development in the second quarter of 2022 and recent events, followed by an overview of our pipeline of clinical and preclinical programs. Then Johnny will provide a financial update after which we will talk about 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 aimed at treating cancer which is resistant to current treatment options. We are among the world's leaders in reverting cancer's resistance against treatment, thus making the treatment work better and longer, thereby potentially prolonging and improving the lives of patients who would otherwise have a high risk of dying from their cancer. This will of course, also improve the lives of the patients' relatives. 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 what actually motivates us going to work every day. We have both 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. Please turn to slide five. The second quarter of 2022 had a number of important achievements as highlighted on this slide. In essence, we continue to execute our plans and strategy to ensure the long-term value creation. We added new strong capabilities to our company, both to the board of directors and to our team. The board of directors saw three highly experienced active leaders from pharma and biotech industry joining, and our team was expanded with Dr. Alfredo Zurlo coming in as Chief Medical Officer. Just this month, we got another excellent addition to the team with the appointment of Lolanda Micco as Director of Medicinal Chemistry. She will work with to broaden our early pipeline, in line with the strategy we have laid out, and I will talk more to this later in this call. We achieved a major milestone in carrying through a rights issue and raising approximately SEK 75 million in gross proceeds. This injection of cash enhances our financial position, meaning that we can now fund the operations into 2024, which provides us with the strategic flexibility and allow us to plan ahead without having to rely on further immediate cash injections. I would like to welcome the new shareholders to Scandion and also thank all shareholders participating in the rights issue for their support. We maintained a good momentum in both our clinical trials, CORIST and PANTAX, during the quarter that we just came through. I'm very excited by our strong capabilities in trial execution, which also gives us a lot of confidence when considering future trials. PANTAX, that's a phase Ib dose escalation trial with our lead asset, SCO-101, in pancreatic cancer. PANTAX was recently extended because we have observed a better than expected tolerability of SCO-101 in that trial. I will speak about this more in detail shortly, but let me just note that this is of course a very positive event, even if it postpones the top line readout to the first half of 2023. We still expect to present top line data from the ongoing second part of CORIST. That's a phase II trial studying SCO-101 in metastatic colorectal cancer. We expect that during the third quarter of 2022 in line with the communicated timelines. The top line data will provide an initial clinical proof of concept or will potentially provide initial proof of concept with the currently used dose schedule in this indication. Please note that as the trial by design will continue until all patients have left it, this data will not necessarily be conclusive at that time point. We will get final data later when the entire CORIST trial is finalized. CORIST will be expanded with parts three and four, for which we are delighted to have received the approvals allowing the development of SCO-101 to continue as planned. We of course also delighted that the recent capital raise allows us to invest in maximizing the value of this potential new cancer treatment. Please turn to the next slide for more details on the capital raise. With our previous cash position funding us into 2023, we had always stated that we would pursue securing additional cash during 2022. To this end, we carried through the rights issue, leveraging our position as a listed company to raise more capital. The gross proceeds of approximately SEK 75 million extends our funding into 2024, and allow us to invest according to our strategy and plans as laid out in relation to the rights issue. Investments include our ongoing trials as well as preclinical development to explore and position the use of SCO-101 and other candidates in combination with, for example, immunotherapy and chemotherapy. Further, a small portion of the proceeds will be invested in the overall development of Scandion as a listed clinical-stage biotech company, and also as an attractive investment case for institutional investors. All of these investments will be made with the intention of increasing the value of Scandion over time to the benefit of all our shareholders. Next slide, please. Our main priority remains the development of SCO-101 in colorectal cancer, and we will commit most of our resources to these activities. As always communicated in relation to the rights issue, we see an opportunity to better exploit the potential of SCO-101 in colorectal cancer by expanding the CORIST trial to also explore RAS-mutated patients. This represents both a great medical and commercial opportunity as we can almost double the potential, in terms of patient population and aim for a position higher up in the lines of treatment. CORIST has therefore been extended with parts three and four. Part three will evaluate the safety and tolerability of SCO-101 in combination with chemotherapy FOLFIRI, when dosed according to a different schedule than in part two over six days. Part three is planned to include up to 36 patients with both RAS wild-type and RAS mutated tumors. After an optimal dose is found in part three, up to 24 patients will be enrolled in part four to assess preliminary activity of this new schedule of combining SCO-101 and FOLFIRI. Please note that since the numbers of patients to be enrolled are not fixed, timelines for top-line results are naturally uncertain. For part three, we expect top-line data most likely in the third quarter of 2023. Importantly, the expansion of CORIST has been done through an amendment of the ongoing trial, allowing us to initiate the expansion while finalizing part two, thereby keeping the momentum in the trial and utilizing the already activated trial sites. After completion of part four, the overall study results will be analyzed to choose the best schedule and the most suitable patient population for further development in colorectal cancer. Please turn to slide eight. As noted, we have been positively surprised by the observation made so far in the PANTAX trial, with tolerability being better than expected. This allows us to escalate the dosing to higher levels than anticipated based on the initial findings in the CORIST trial. We of course do so in order to find the optimal dose of SCO-101 in this indication and combination and potentially others. This is positive in itself, and it also supports the overall profile of the compound as a well-tolerated compound in vulnerable patients. The continued dose escalation extends the study, meaning it is now expected to read out in the first half of 2023 rather than in the third quarter of 2022 as previously expected. The data from the trial will determine optimal dosing and helping us to plan potential further development in pancreatic cancer and all other indications. Next slide, please. This slide gives an overview of our pipeline, illustrating that SCO-101 is our lead asset with potential in multiple cancers and also in combination with immunotherapies, which we are studying on a preclinical level. We are also conducting preclinical activities with our second molecule, SCO-201, in solid tumors. What you cannot see from the slide is our catalog of approximately 800 compound analogs that could potentially hold one or more development candidates. With Lolanda Micco on board as Director of Medicinal Chemistry, we are now able to initiate the work to screen these compounds and potentially locate any hidden gems within our library. This will of course take time, but could provide new potential cancer treatments that we could add to our early pipeline as development candidates. Expanding our pipeline in this way would give us even more opportunities to make a real difference for the many cancer patients that today don't have effective treatment options. With that, I would like to hand over to CFO Johnny Stilou, who will update you on our financials. Please go ahead, Johnny. Thank you, Bo, and please turn to slide 11. On this slide, you can see our financial results for the second quarter and the first half of 2022. It is a pleasure to once again state that the results are in line with our expectations. We follow our investment plans and are in good control of our cost. We invest primarily in research and development. We have invested significantly more in 2022 than in 2021, as we have advanced both the CORIST and PANTAX trials and thereby enrolled more patients. In general, the trials become more and more expensive as they recruit more patients, and then costs are reduced as trials are finalized. General and admin costs represent the investment in our people and company. As expected, these costs are plateauing as we have completed the buildup of our organization through a number of hirings during the past 18 months. Please note that our current cash position is stronger than reflected on this slide, since the proceeds from the rights issue were not booked before the end of the second quarter. Moving on to slide 12. As you can see on this slide, our cash spend increased in the second quarter, primarily driven by the increase in R&D investments. We do not expect to maintain the spend when the clinical trials are finalized. That also means that one cannot simply extrapolate the spend in the second quarter if trying to calculate our cash runway. Also remember that spend is likely to fluctuate between quarters. As mentioned before, our current cash position is higher than reported on this slide, since the proceeds from the rights issue were only received after the end of the second quarter. Including the net proceeds from the rights issue, our Q2 cash position totals close to DKK 115 million, which funds our operations into 2024. This also implies that additional funding is needed sometime during 2023. With that, I will hand the word back to Bo. Thanks, Johnny, and please turn to slide 13. We are looking forward to 12-15 exciting months for Scandion, with more significant events expected. The first being the top-line data from the ongoing second part of CORIST expected this quarter. As mentioned, the top-line data could provide an initial clinical proof of concept for SCO-101 with the currently used dose schedule in this indication. Please also note that we will get the final data later when the entire CORIST trial is finalized. Independently of CORIST part two, we expect to commence patient recruitment for part three of the trial during this quarter. In this event, we would expect top-line data from part three in about a year's time, upon which we can make decisions how to conduct the fourth and final part of CORIST. Top-line data from PANTAX is expected in the first half of 2023, following the extension of the study based on the continued dose escalation that I spoke to. The data will support the overall profile of SCO-101 and help us plan potential further development in this and all other indications. Let me just remind you that the execution of the trials mentioned is covered by our current cash position that takes us into 2024. Again, a lot to look forward to in the future for us at Scandion Oncology. Next slide, please. As always, we prioritize the profiling of Scandion Oncology 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. It is important for us to communicate so that these points will be visible to stakeholders. To this end, we have been active participants on a number of conferences, and we will continue to be going forward. We are looking forward to present at both local, meaning Scandinavian and international conferences in the coming months, as outlined here on the slide, and are always open to opportunities to present Scandion to relevant audiences. Please turn to slide 15. In conclusion, Scandion had a successful second quarter, achieving a number of milestones as we continue to deliver on our strategy. We remained focused on our priorities, first and foremost, the execution of our clinical trials and are looking forward to the imminent readout of top line data from CORIST part two, while also preparing the start of part three and continuing PANTAX. We will continue to leverage our strengths as first movers in cancer drug resistance with both a significant medical and commercial potential. We have de-risked SCO-101 and our pipeline provides several opportunities to expand into different therapy combinations and cancers. We have built a strong organization of seasoned leadership team and are ready to further develop the company and our pipeline. With all that, I conclude our presentation and thank you for your attention. We are now ready to take your questions. Again, please remember that you can only state your questions verbally. Back to the operator. Q&A session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Harry Shrives with Edison Investment Research. Please go ahead. Hi, Bo and Johnny. Thanks for presentation and congrats on the quarterly results. First off, I'm interested in CORIST part three and in particular how the company's intending to address the mutant RAS population. Could you comment on how confident you are that SCO-101's profile in these patients can be improved through some modified dosing? Yes, thank you for the question, Harry. Yeah, I mean, as we've stated, along the way, we have never actually given up on the RAS mutated patient population in metastatic colorectal cancer. We have merely said that we totally require an optimal dosing. With the learnings from our CORIST studies so far, we are confident enough to initiate the part three with an optimization of the dosing schedule, also putting the RAS mutated patients in the range. This is of course a strong commitment to us believing that the SCO-101 in combination FOLFIRI can make a difference for the entire patient population. Okay. Thank you. Moving on from that, yeah, we've got now CORIST part three and part four that are gonna be happening. You've mentioned the timelines for CORIST part three, but can you elaborate on how the new expansions of the CORIST trial are gonna affect the sort of full development timelines for SCO-101 and when we might be able to expect sort of pivotal trials in colorectal cancer? Yes. CORIST part three and four will be concluded before we will enter into a pivotal trial in metastatic colorectal cancer. The overall timelines, development timelines are not expected to change from that part. Merely we are broadening the patient reach, you can say or the patient population that we can reach and thereby also the commercial potential in order to position a pivotal trial best. The second part of that equation is also in order to commence into a pivotal study, we would have to secure the entire financial resources for conducting the pivotal trial. As in terms of overall timelines, we are not expecting this to change the picture. Okay. Thank you. My last question goes on from that, quite nicely. With respect to the licensing strategy, have you got any sort of feel or idea of what a potential partner might be looking for from SCO-101 in terms of the clinical data, the patient reach, things like that? In terms of our conversations with potential partners, obviously I cannot reveal any details on a call like this. All I can say is that there is, in general, interest in new treatment options for patients resistant to chemotherapy and in these indications where we are positioning our development at the moment. Great. Thank you very much, Bo and Johnny, and congratulations again on the call today. Thank you. Thank you. Again, if you have a question, you may press star and one. The next question is from the line of Christian Binder with Redeye AB. Hi, and thank you so much for taking my questions. Just one from my side. For clarification, looking at the CORIST parts three and four, I assume you will still recruit last line metastatic colorectal cancer patients or are those gonna be second line already as you previously discussed, potentially moving into second line. Then, longer term, do you still plan to move into second line or is that still to be decided based on the results that are coming? Hello, Christian, and thanks for the question. You are correct in that part three patients will be recruited from last line patient pool, now expanding it to also include RAS mutated patients. Our company and our approach to this is of course we are as always science and data-driven. Our plan is still to explore the potential to move the future therapy up the line and thereby also positioning it accordingly when we see the data from part three and four. All right. Perfect. Just a quick follow-up to that, and also tying into potential pivotal trials. After part three and four, do you think it will be possible to directly, for example, start a Phase II/III trial in second line? Or do you think there will be some more work required before you could potentially move into pivotal trial in second line? Again, potentially, yes. Now it's difficult to, you know, to come with a very definite answer as I don't know what the results will look like from three and four. We are encouraged by the fact that we will go in and study in this patient population and could expand this into a pivotal trial also, potentially looking at moving it up the line. I mean, all of what you ask is within the name of the game of the possible, based on what we are doing now. Got it. All right. That was all from my side. Thank you so much. Thank you. A reminder to all participants, if you have a question, please press star then one. Again, if you have a question, please press star then one. Ladies and gentlemen, if you have a question, please press star then one. This concludes our question and answer session. I would like to turn the conference back over to Bo Rode Hansen for any closing remarks. Okay. Thank you. Well, I mean, this concludes our conference call. I would like to thank you all for attending this Q2 2022 interim statement call. You may now disconnect your lines. Have a nice day. The conference has now concluded. Thank you for attending today's presentation. You may now dis-.
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