Hello and welcome to the Scandion Oncology Audiocast with Teleconference. With us today we have CEO Bo Rode Hansen and CFO Johnny Stilou. For the first part of this call, all participants will be in a listen only mode, and afterwards there will be a question answer session. I will now hand over to the speakers. Please go ahead. Thank you. Good morning everyone, and thanks for listening in. Welcome to our Q4 2021 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 also our CFO, Johnny Stilou, and we will be updating you on the development and financial results for the fourth quarter of 2021, as well as some recent events. Overall, it was another productive quarter for Scandion, with good strategic progress as we moved our clinical and pre-clinical programs forward. We remain on track for readouts from our two clinical trials later this year. Following our presentation, we are also happy to take your questions. Again, welcome and thank you for your interest in Scandion. Next slide, please. As always, before we begin, let me just remind you that we'll 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. Let's move to slide 3 for the agenda. In our call today, I will update you on the development in the fourth quarter of 2021 and recent events before presenting our pipeline of clinical and pre-clinical programs. Johnny will take you and provide you a financial update after which we will talk about expected milestone events for 2022 and our external profiling activities ending with a reminder of our core strengths. Next slide, please. At Scandion, we discover and develop first in class medicines aimed at treating cancer which is resistant to current treatment options. In that way, we are among the world's leaders in reverting the cancer's resistance against treatment, thus making the treatment work better and longer, and thereby potentially prolonging and improving the life of patients who would otherwise have a risk of dying from their cancer. This will, of course, also improve the lives of the patients' families and relatives. I remind you that globally close to 10 million patients lose their life every year from treatment-resistant cancers. To us, that is simply unacceptable. Help bringing this number down is what really motivates us and gets 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. In 2022, we hope and expect to take significant steps towards realizing this potential. Please turn to slide 5. The fourth quarter completed a busy and successful 2021 for Scandion, in which we transformed the company on substantially all accounts. We have strengthened our lead compound, SCO-101, our trials and pipeline, as well as our organization. In a challenging year, we have in this way successfully transformed the company and improved its fundamental value as a world leader in fighting cancer treatment resistance. We are prepared for a future with continued focus on fundamental value creation and entering the right partnerships for Scandion when the data are ready. We had a setback in the fourth quarter. I have to say that, and the delay we saw in the PANTAX trial, came to us. Importantly, the trial remains ongoing and is performing well with expected readouts in the second or third quarter of the present year. We have also had an eventful start to 2022. We continue to strengthen our team of seasoned specialists from the life science industry and with the addition of Mads Kronborg to help us lead and further improve our external communication. Mads brings more than a decade of experience from managing positions in corporate communications in the pharma and the life science industry, that being Lundbeck, the second largest pharma company in Denmark, and Zealand Pharma. We are looking forward to benefit from his expertise in profiling Scandion. Also in January, we had the pleasure of having data from the CORIST trial presented at the ASCO GI Conference, and I will come back to that important event shortly. I will also elaborate on the recent internationalization of the CORIST trial and how that strengthens us in multiple ways. Next slide, please. Yeah, as I said, it was a great pleasure for us to have data from the CORIST trial studying SCO -101 in combination therapy in patients with metastatic colorectal cancer accepted for a poster presentation at the big international ASCO Gastrointestinal Cancers Symposium in January. The data presented provides details to the top-line results communicated earlier, documenting the unique mode of action for SCO-101, which provides a significant potentiation of the chemotherapy irinotecan. This confirming the potential of SCO-101 to significantly improve treatment options for patients. As you can see on the slide presented here, the combination of SCO-101 irinotecan resulted in a dramatically increased exposure and half-life of SN-38, which is the active metabolite of irinotecan. In other words, SCO-101 has the potential to make this chemotherapy much more effective without increasing side effects for patients. The poster presentation was done by the lead investigator of CORIST, Jakob Veser-Huskow. To have data presented here means it has been communicated to a large audience of more or less every expert and researcher in the field of cancer drug resistance globally. It also means it has been peer-reviewed and selected for presentation. This is a fantastic exposure of the data, the trial, and the compound, and it created great attention and interest. Furthermore, it is a validation of Scandion that the data were accepted for presentation at a symposium of as important as ASCO GI focused conference. It strongly supports the perception of the company as a frontrunner in the cancer drug resistance field. Please turn to slide seven now. The CORIST trial is ongoing, of course, and we were pleased to announce earlier this month the internationalization and expansion of the trial, which enables us to also recruit patients in Germany and Spain. So far the trial has been running in Denmark, and the expansion is expected to support both the recruitment of patients to the trial. Further, it will help increase the awareness of SCO-101 with authorities and leading international investigators. The internationalization of CORIST follows the earlier internationalization of the other trial, the PANTAX trial that we have, which is a phase I-B. Both expansions show how we align with our strategy of scaling up our efforts in clinical development as we are building capabilities to conduct clinical trials in all relevant countries, including the U.S., as well as conducting randomized pivotal trials going forward. This will allow us to pursue co-development partnerships or independently develop our molecules depending on how we can best create maximum value for patients, for caregivers, for Scandion and our owners. Next slide, please. This overview 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 it's 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 stated, readout of CORIST is expected in the second or third quarter of the present year. Positive data confirming the data we already have will allow us to start planning the pivotal development which we will seek to conduct in one or more partnerships, potentially starting in 2023. The second trial, PANTAX, is a phase I-B trial in patients with unresectable or metastatic pancreatic cancer. The study is designed to provide us with data on optimal dosing of SCO-101 in combination with the standard of care nab-paclitaxel and gemcitabine, which is first or sometimes second-line therapy in this hard to treat indication. This will allow us to plan a clinical proof of concept trial, and PANTAX readout is also expected in the second or third quarter of this year. I would like to remind you that, biomarker identification is part of both of these trials, and, this will help us to identify patients from whom the treatment may be most efficient, meaning that we can target or personalize the treatment, which is very important when developing cancer treatments. Coming back to the broad potential we see for SCO-101, we are also conducting pre-clinical studies in which we combine the compound with, immunotherapies. We've talked about this in the past. 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 Scandion. Finally, we are also conducting pre-clinical activities with our second molecule, SCO-201, in solid tumors. In conclusion, we have a number of opportunities to make a real difference for patients with cancers that today don't have effective treatment options. With that, I will hand over now to our CFO, Johnny Stilou, who will update you on the financials. Please go ahead, Johnny. Thank you, Bo. Please turn to slide 10. This slide provides a summary of our financial results. I'm pleased to say that they are as planned, reflecting that we have executed on our investment plans and maintained good cost control. That also means that our cash position is as expected, and that we remain fully funded into 2023, as also previously announced. Essentially, our investments fall into two categories: our organization and our molecules. The first is reflected in our staff costs, which are up compared to the fourth quarter of 2020, reflecting the continued build-up of our team in 2021. As our organization is now in place to execute on our strategy, staff costs are expected to stabilize around the level of the fourth quarter of 2021. Investments in our molecules are reflected in the other expense line. The increase here is driven primarily by the advancement of the CORIST and PANTAX trials, and we plan for a continued increase in cost in the first half of 2022 as the trials recruit more patients. Moving to slide 11. Following a cash spend in the fourth quarter of 2021 of DKK 11.7 million, we ended the year with a cash position of DKK 105.7 million, meaning that we can fund our operations into 2023. As noted just before, we plan to increase our investments in 2022 as we progress our clinical trials and enhance our opportunities for long-term value creation. With that, I will hand the word back to Bo. Okay. Thank you, Johnny. I would say please turn to slide 12. 2022 is a very exciting year for Scandion, with the two expected readouts from our clinical trials giving us actually a double shot on goal. As mentioned earlier, CORIST will hopefully provide the clinical proof of concept for SCO-101, confirming our pre-clinical findings in patients. The primary efficacy objective is assessment of response, so that means tumor reduction. Secondary objectives include assessment of clinical benefits, like duration of stable disease, progression-free survival, overall survival, as well as 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 PANTAX, as also mentioned, it will hopefully provide us with data on the optimal dosing, and thereby paving the way to move into phase II with a randomized control trial that could provide a clinical proof of concept for SCO-101 with yet another group of chemotherapy in pancreatic cancer this time. Again, a very exciting year for us. Looking forward to these readouts. Next slide, please. Further to developing our molecules and company in essence, we continue to prioritize the profiling of Scandion through proactive communication with external stakeholders. Our journey towards delivering new treatment options for cancer patients requires long-term focus and insights, and there will be many value inflection points along the way. These need to be visible to stakeholders, and therefore communication is as always very important to us. To this end, we have been active participants on a number of both local, so Scandinavian, and international conferences where we will continue to be as we move forward. We're looking forward to present at the Swiss Nordic Bio in March and at the Anglonordic Life Science Conference in May. Please turn to slide 14. In conclusion, Scandion progressed well in the fourth quarter and all of 2021, and we will continue to execute on our strategy in 2022 too, during which we have at least two potential huge value inflection points with the readouts from CORIST and PANTAX. We will continue to leverage our strength as first movers in cancer drug resistance with both a significant medical and commercial potential. 2021 saw us de-risk our lead asset, 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 we are ready to further develop the company based on hopefully positive outcomes of our clinical trials. This could be a landmark year then, not only in the history of Scandion, but also for the treatment of cancer drug resistance. With that, I conclude our presentation today, and thank you again for your attention. We'll be happy to address and take your questions, and thereby I conclude and give the word back to the operator. Thank you. Thank you. And if you do wish to ask question, please press zero one on your telephone keypad. If you wish do to withdraw your question, you may do so by pressing zero two to cancel. We have a question from the line of Christian Binder from Redeye. Please go ahead. Good morning, and thank you so much for taking my questions. Several, if that's okay. To start with, Bo, could you just elaborate on which main value creation events do you think Scandion has passed during 2021? And then also, what do you regard as the main value inflection points in the next 12-24 months? Yes, good morning, Christian. Thanks for the question. I mean, fundamental value is increased through numerous steps, I would say. Most importantly, the build-up strengthening of our organization and an introduction of a clear strategy and operating model, coupled, of course, with the de-risking of SCO-101 that I just spoke to. In essence, we have built a platform for long-term value creation, which is our focus, and that is what we prioritize, rather than running the company based on, you could say, the day-to-day share price development. In that sense, in terms of inflection points, the most imminent and concrete are, of course, the readouts from CORIST and PANTAX in Q2, Q3. We are all looking forward to those. And then, we will likely have several more further down the line. I mean, it gets a bit speculative to comment on since it depends on the data. A lot depends on the data from these two trials in how we direct that. Then I also think that the preclinical validation of SCO-101 in combination with immunotherapy is something that we think is a thing to look out for in the time to come. Right. That's really helpful. My second question regards CORIST. You also have the positioning study. I just wonder timing of that readout. Does that affect your ambition or rather timing of starting a pivotal trial in 2023? Or do you believe that you're set to start a pivotal trial in 2023 irrespective given that the data looks good of course? Mm-hmm. Yeah, again, thanks for the question. The readout from CORIST Part 2 is planned. I'm just repeating myself, for Q2, Q3 of 2022. As previously communicated, we also plan to initiate a pivotal trial, could be phase II, phase III in 2023. We don't necessarily see an interdependence with the positioning study to do that. The timing is as we expect and we still hold the expectation to go for pivotal trial in 2023. Okay, great. Last question regarding PANTAX. I just wondered regarding the dynamics of transitioning from phase I-B to phase II. Do you believe, contingent on a positive readout from phase I-B, of course, that you could start recruiting patients during 2022 already? Or would that probably occur more during early 2023? Yeah. Theoretically, that could be possible. However, it is difficult to know before we have really concluded the phase I-B. By that I mean to be precautious, both because of timing and data. If I-B reads out late in Q3, that would not leave much of the 2022 to start a new trial. The design which would depend on the I-B readout in any case, but theoretically it's possible. Okay, great. That was all from my side. Thank you so much. Thanks. Just as a final reminder, if you do wish to ask a question, please press zero one on your telephone keypad now. There seems to be no further audio questions, so I hand it back to the speakers. Thank you. Yes, we have received a number of questions online, so I will pose a few of them here. We have a first question that asks, you call the patients in CORIST third line failures. Does this mean they are in fact in fourth line or later? The actual nomenclature here is, I mean, inclusion into CORIST means that they have been in third line therapy on FOLFIRI, and they have become resistant to the FOLFIRI treatment, and as such have progressed, and then they come into our trial. Okay. Thank you. We have a question here. Is there any information from JPMorgan or Biotech Showcase you can share with us? I think in general, we update on events. What I can say is that we have had an active presence in both of those conferences. I think that as such, the company is visible and is active in the space of positioning Scandion and our pipeline in the awareness of the industry partners. Thank you. We have another question. How did Scandion Oncology get such a seasoned Clinical Advisory Board? Again, thanks for the question. I do share the view that we have a top-notch, stellar Clinical Advisory Board. I mean, I think it goes to show that this is very important. I mean, 90% of the casualties of the lives lost in cancer are due to resistance to the existing treatments. This topic and a new molecule with a unique mode of action, it just appeals to the attention of these industry thought leaders. As such, in all humbleness, I think this just goes to show that we are touching on something important here in the work that we're doing. Thank you. We have another question. Have you explored further immuno-oncology combinations with SCO-101 other than the one you did with Alligator? We have done more studies than the one with Alligator. We are happy to communicate about and, you know, answer questions related to generally the operations and development of Scandion and our pipeline. I think for a number of reasons, there are competitive considerations and IP and so on. We will not communicate all details to the outside until we are ready. As I've said numerous times, we are excited about the findings, the preclinical findings that we have had, combining SCO-101 with the immunotherapy agents, and we will explore and exploit that further into the benefit of patients in need. Thank you. Another question here is, what does potential partners, license takers want of you to engage in a collaboration or partnership? Again, in general, there are many details in such a question. As a general theme and thinking about partnerships, de-risking, understanding data, seeing data, and the readouts is important for any partner in order to engage into a discussion and into a partnership. Okay, thank you. We have another question. Will there be any analyst coverage from Edison? I can take that one. We, as you all saw or may have seen, we attended an Edison conference here, late January, and there was also a note done by Edison. Edison is a company which provide paid-for research. We are continuously looking into analysis and research performed, and also both to address Scandinavia, Europe, and the U.S. Edison could be one player here which we could be considering. Thank you. We have another question here. Is there an active interest from other players in the field when it comes to immuno-oncology and SCO-101? In general, again, I'm happy to communicate about speculative interest and but in general, the field of immuno-oncology is large, and it's expanding and increasing. As such, any agent that can improve efficacy and outcome of immuno-oncology would potentially be interesting to the community and the treatment of cancers. Thank you. We have a question here. Have you applied for IND to open studies in U.S.? The U.S. presence is part of our strategy and, as such, we will be very happy to update the market on progress in that direction when that is ready. Thank you. We have a question here. Could you elaborate on how Scandion is currently working on the immuno-oncology track and what can be expected for 2022? Do you foresee a need to raise funds in 2022, and what are the likely means to raise such funds? Okay. I think the last part of that question, I'll just pass it to Johnny, because this is fundamental. Yes, thank you. As I mentioned, our current funds is progressing according to our plans and expectations and will fund operations, planned operations into 2023. We do not have any imminent need for any additional funding. As we have informed earlier and also at our Capital Markets Day, funding can come from a number of sources, including equity, debt structures, and partnership deals, or in a combination of these three means. We at the company are continuously evaluating all three parts as potential future funding of our progression of our studies. Thank you. With that, we have no further questions. Okay. This concludes our session for today. Thanks a lot for the interaction and for the questions, and happy to hear and meet you next time at the next event. This concludes our conference call. Thank you all for attending. You may now disconnect your lines.
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