Thank you. Let me bid all a very warm welcome to this Scandion Oncology audiocast at financial hearings. I want to welcome our long-term and existing shareholders, and also any new shareholders that came to us recently, and of course, everyone else. My name is Bo Rode Hansen, and I'm the President and CEO of Scandion Oncology. I'm here seconded by our CFO, Johnny Stilou, to present our half-year report that we just sent out this morning. There will also be a Q&A at the end of the session. Next slide. On slide two, we have a disclaimer because the presentation will be containing forward-looking statements. Next slide, slide three. It's been a very strong quarter for Scandion Oncology. I would say one of the best with results, both from our clinical development and our pre-clinical development, strengthening of the team, and so on. Today, I will take you through the highlights of the quarter and also dig into where are we with our clinical pipeline. Then we'll focus on the financials from the second quarter and speak a bit to the outlook and what we're expecting in terms of milestones in the next coming period and looking forward. Next slide, slide three. Slide four, sorry. Let's look at the most important highlights from Q2. As I said, I am very excited with the performance that we have managed to do. We are internationalizing the company, including the people around us, and we announced in the quarter that we managed to attract former or past President of ASCO, Richard Schilsky, as a member of our sprouting Clinical Advisory Board. We also strengthened our internal team. I was pleased to announce that Johnny, who is here with me today, was appointed the new CFO of the company. We have also managed to deliver on our promises in terms of milestones. We presented in June positive interim results from the CORIST trial, our most advanced clinical development trial, and we will speak more about that. We also showed pre-clinical data from the ongoing collaboration with Alligator Bioscience, where we have seen that we can validate the use of SCO-101, together with immuno-oncology in a pre-clinical setting. I will give you a more granular view. Let me remind you that we are hosting a capital markets day on September 8th, which we announced in July. Next slide. We're on slide five. What did we actually see in the CORIST trial? Let me recap here. We announced in June that we completed the first part of our CORIST trial, which is studying SCO-101 together with FOLFIRI in metastatic colorectal cancer patients that have failed prior FOLFIRI treatment. We met all the objectives that we have set out to do in part one. We found a well-tolerated dose of SCO-101 in combination with FOLFIRI, which is a very important result when you are developing a new medicine. Additionally to that, we also found that we could segment our patients based on a biomarker, the RAS oncogene, which enables us to use this as inclusion criteria in the second part of the study, and thereby de-risks the second part of the CORIST trial. We are now advancing and is ready to dig into our second part of the study, which is the proof of concept part. Very important results. Next slide. This is slide six. The second piece of news that I already alluded to, position a pre-clinical validation of SCO-101, so our lead compound, together with chemotherapy and immuno-oncology agent, in this case, Alligator Bioscience CD40 antibody. This was, of course, conducted in collaboration with Alligator, and I think it's an important result. It's an early result, but it does actually give us purpose to explore this concept further, and we will take full advantage of that and explore the area of immuno-oncology as we move forward. Next slide. That's slide seven. What is it that we can say and why am I so excited at this point about SCO-101? I think it's even better said with an external comment coming from a veteran in the field of oncology, Benny Vittrup, who's the Head of Pancreatic Cancer Center at Herlev University, but also has pioneered the use of antibiotics and work with GI cancers for a lifetime. He states here, it's in his opinion that SCO-101 with its dual action is one of the most exciting new opportunities in the development of new treatment options for patients with metastatic colorectal cancer that he has seen in the past 15 years. There's an interview with Benny in our recent report. Next slide. We are on slide eight. Focusing in on SCO-101, here is a view of our clinical development pipeline. With this first-in-class medicine, we have two trials ongoing. We have the CORIST trial that I just spoke to the results from the first part of, which is now entering this part two of the phase II, and we have the PANTAX trial, which is in a different cancer. This is in unresectable or metastatic pancreatic cancer patients. There we are currently running our phase I-B, which is a dose-finding study that we expect to report data on later in the year. If we look at the highlights here, we kept our promises on delivering on CORIST part one, which was reported on June 24th. In terms of the upcoming key events, in CORIST, we are now with the amended part two starting up in Q3, so in this quarter. In terms of PANTAX phase I-B, we are expecting to have and keep the planned readout in the course of Q3, Q4. I also want to stress that you have to bear in mind, Scandion Oncology is not a one-drug company. We also are exploring and building a pipeline underneath SCO-101, but I won't speak further to that today. Next slide. This takes us to the financial update, and I will pass over to Johnny Stilou on the next slide. Thank you, Bo. Yes, if you move to slide number 10, which provides a financial overview of the financial performance in the second quarter of this year, you can see that the net result amounts to a loss of DKK 12.5 million. This is derived from the areas of staff cost of DKK 5.3 million, other expenses of DKK 10.1 million, and then a tax income of DKK 2.7 million. Compared to a similar quarter of 2020, this is an increase in cost, as you can see. It's also an increase in the cost areas compared to the first quarter of 2021. Staff cost shows an increase of DKK 1.3 million compared to the first quarter of 2021. This is due to increase in the organization strengthening, both in our clinical team to progress our clinical studies, the CORIST and PANTAX, and also to strengthen our research capabilities, as Bo mentioned, in connection with our pipeline build. The other expense line, the DKK 10.1 million, that is an increase from the last quarter, which showed DKK 5.9 million. The increase is driven by clinical cost to progress the CORIST and PANTAX and is fully in line with our expectations. The line item other expenses consist of two areas. It is the R&D cost, the clinical cost I just spoke about. Further, it is what you would call general and admin. That is our lease cost and so on. By far majority of the cost is clinical external cost, mainly coming from CRO, clinical research organizations, assisting us with the clinical development. The tax line shows an income of DKK 2.7 million. In Denmark, you have a tax credit whereby companies that perform research can get a tax refund capped at DKK 5.5 million on an annual basis. Scandion is eligible to receive this tax refund. By the end of the first half, we have in total, as you can see, accrued DKK 5.1 million. That means that in the third quarter, this tax income line will decrease and show approximately DKK 350,000, reaching the cap of the DKK 5.5 million. As said, this gives a net loss for the quarter of DKK 12.5 million. Next slide, please. There you have an overview of our cash position. As the headline says, we have indeed a very strong cash position currently. We have in total as of end June, DKK 131 million in the bank. In the quarter, we spent DKK 13.7 million, which is driven by the net loss of DKK 12.5 million in the quarter. The result and our cash position is fully in line with our expectations. There are no changes to our projections going forward, which also means that we restate our expectations that our current cash position will fund the company until at least after 2022. With that, I would like to hand the work back to Bo. Thank you, Johnny. I will continue now on slide 12. Next slide. Just to reiterate, what are we expecting? What are we seeing in the nearby future in the course of 2021, 2022? The CORIST study that has been a lot of focus, Q3 this quarter, we are initiating the second part of the study, which is the proof of concept phase. In terms of our second clinical trial, PANTAX, we are expecting in the course of the already reported timeline, Q3, Q4, to have a data readout from the dose-finding part of that, the phase I-B study. In terms of longer-term milestones, it's of note that the proof of concept readout from CORIST, which is an important inflection point for the company, is anticipated in the timeframe Q2, Q3 of 2022. This will be a point to look out for. As Johnny spoke to, our finances are securing us through that, and at least until after 2022. With those significant events in mind, let's take the next slide, and let me just say, if you sit and listen and you only take three take-home messages here, I would say bear in mind, Scandion Oncology is pioneering a field, developing a first-in-class therapy that can revert resistance towards existing anti-cancer agents. This means that we can tap into an existing market. The market of chemotherapies is on the rise. It's very large. We have de-risked our lead compound, SCO-101, in two clinical trials right now. We have reported the results from the first part of the CORIST trial. We are building the company and the structure, have brought on significant expertise to add to the already existing team and complement, and is internationalizing the company in that regard. By that, we are clearly focused on creating value for patients and our shareholders. Next slide. Let me remind you on some important upcoming events for the company. As mentioned, our Capital Markets Day will take place September 8th, and I encourage you to participate. We will have our next financial reporting on November 18th, where we will release the third quarter numbers, and our year-end report will be on 17th of February. There will be plenty of other events that you can find on our event calendar, which is updated on the Scandion website, and where you can find out how it fits with your schedule and where to meet the company and listen in on our science and our progress. Next slide, please. This takes us to the end of this quarterly hearings, and be happy to engage into a Q&A. Thank you. If you wish to ask a question, please press zero followed by the one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero followed by the two. Once again, to register for a question, it's zero followed by the one on your telephone keypad. Our first question comes from Christian Binder from Redeye. Please go ahead. Your line is open. Good morning. Thanks for taking my questions. I have several, if that's okay. First of all, in June you mentioned that you were looking at recruiting additional trial sites for CORIST phase II part two. Could you give any update on that? Good morning, Christian. Thanks for the question. Yes, we are looking at internationalizing our trial sites. All I can say is that we are on track and expecting to keep our timelines also in that regard. Right. Thank you. The second question. Scandion is set up well for CORIST phase II part two. However, there's going to be no control group, right? Part of the outcome measures is going to be efficacy, and while patients have been FOLFIRI resistant previously, the literature seems to suggest that there may be a potential for re-challenge. In your view, could you just guide us on looking forward how we should approach looking at the data that will come with CORIST phase II part two? Yes. Again, thanks for the question which contains several parts. Let me address first, the question of re-challenge, as you bring it up, where patients who have progressed on FOLFIRI is treated with FOLFIRI again, it has been raised. To really answer that question, it requires a statistically powered control study. Our CORIST study is not designed to answer this particular question. As you know, we don't have a control arm. This I cannot address, but what I want to say is that our CORIST trial is divided into the two parts, a dose-finding part and a proof of concept part. We have now successfully finished the dose-finding part and have determined the dose that will be used in the proof of concept part. What we are looking for in the proof of concept part is any response to the treatment for FOLFIRI and SCO-101. This trial, there has to be a response according to the international guidelines, also known as the RECIST criteria. The proof of concept trial is therefore not a trial that compares two treatments but establishes effects of a new treatment. First, later, we'll be able to compare chemotherapy and SCO-101 with a standard treatment in order to see if it's superior in a randomized control study. I think that addresses the points in your question. Yes, thanks. That was very informative. A last question. Can we expect more data from the immuno-oncology collaboration with Alligator to be published? It may be very early, but have you already identified a potential cancer type and immuno-oncology drug that could be targeted for initial clinical development? I think, as I also tried to be very clear on in my presentation, these are very encouraging results. We are very excited about them. This is also early days. It's preclinical results. The very first set of in vivo data are, as I said, encouraging. The studies will continue to draw the final conclusions, but this first assessment is actually supporting our hypothesis, and it opens for a novel opportunity in our R&D strategy. I think we should allow the plans to sediment and can discuss our strategies also at our upcoming Capital Markets Day. I think this is, you can say, a potential game changer if our hypothesis also stacks up in further studies. All right. Thank you so much. That was all from my side. Thank you. Thank you. As another reminder, to register for a question, please press zero followed by the one on your telephone keypad. There will be a brief pause whilst questions are being registered. Thank you. There appear to be no further questions. I'll return the conference back to you. Okay. Do we have questions from the chat? Yes, we have received some questions from the chat. We have a first question for Bo. You are clocking almost a year as CEO in Scandion Oncology. What has been your biggest challenge so far, and what do you consider will be your biggest challenge over the next 12 months? Yeah, I think that's a nice question. I came in as CEO 1st of October of last year, so I've been here a little more than 10 months. As the followers of the company will recall, we started out by financing the company in order to secure finances for the operations and the plans. This is always a challenge. Fortunately, I came in with a company that was already established. What I'm looking at is really making sure that we build a company to last and that we bring on the right competencies to secure our journey and to complement what is already in place in a maturing company that has gone from an academic spin-out to a clinical stage biotech company. I think in that regard, there are several challenges. One challenge is also to make sure that everything from selling the dream and making sure that the plans and that the world behaves in a fashion that we can deliver on our promises. That requires focus, and it requires structure, and it requires competencies. From that perspective, I think we have been quite successful in attracting new competencies to the company and making sure that we, at the same time, delivered on our promises and the milestones that were set out at the beginning of my time as CEO. Thank you. We have another question. When will there be an EGM? I get that question of an EGM, meaning an extraordinary general meeting. I can say we are planning an EGM. I can't give the specific date. I can say our EGM will be in plan for the second part of September of this year. Thank you. Another question, many companies send out press release when they file patent applications. Scandion Oncology does not. Is this somehow related to business development, or can you elaborate why you have this strategy? Well, in general, what I can say is that we would like to serve the right picture of value creation in Scandion Oncology to the market and to the external world. We can always discuss what is the strategy, whether we file a patent or whether we have a patent that's actually granted. I think the latter is really of value. I think that as we move forward, we will try to focus our communication on value-creating events that the market can use to evaluate and de-risk their investment into the company. Thank you. We have another question. In CORIST from the Kaplan-Meier plot, you mentioned five out of eight patients still ongoing after eight weeks. It also looks like three or four patients also passed the 16-week scan. Can you comment on this? In details, I don't have all the data in front of me at this call. In general, we have completed part one of the CORIST trial. We still have patients continuing on trial, meaning that they are dosed. In terms of the specific for the Kaplan-Meier plot, I don't have it in front of me here to address this. I suggest that this could be a question for follow-up with our clinical team. Thank you. A question, have you expanded your clinical programs to more hospitals for both PANTAX and CORIST to get more patients? I can say that we are following our plans to expand the clinical trials and that we are expecting to be able to keep the timelines that have been set. Thank you. We have a question to Johnny. What attracted you to Scandion Oncology? What attracted me to Scandion Oncology is the fact that it is a company where I see significant potential, a potential to make a huge difference for critically ill patients, which is, from a personal point of view, a significant driver for me. Also looking at the company and the data that I saw in connection with the company, to me, they look very promising. I believe that the company is at an interesting stage. I can see some coming inflection points for the company for value creation, which interests me also. From a personal point of view, you can say that the fact that I have significant experience from biotech, from listed companies, both in Denmark and in Sweden, of course, was also a driver for me. The ability to make a difference, to help build the company, and take it to the next level. Thank you. We have another question. What indication will be next in clinical trials? Earlier reported, ENDORISK at the end of 2021. In terms of our clinical strategy, it's something that we will cover in more detail at our capital market stage. To the question now, our prospectus includes financials raised for the current clinical trials, and that's where our focus is. In terms of what will come next, will be as a part of a strategic discussion in that regard. Thank you. Another question. After the phase II data, Redeye increased the fair market value rate by the de-risk due to the data, but decreased again due to the RAS mutation. In the report, Bo is pointing the RAS mutation as a positive factor. Bo, can you describe the positive and negative value of the RAS mutation, and will the total market for Scandion decrease due to this? Yes. Again, a couple of questions in the question. In terms of the value of segmenting the patients and having a biomarker for precisioning the medicine, I think that's a clear strengthening. It's also a de-risking, and as I said when we presented the CORIST data, we have not forgotten about the RAS-mutated patient or the tumors with RAS mutation. In terms of the strength here, the more you can say about the precision of targeting your medicine to a population, the stronger it is in my view. This just means that the likelihood of success increases. This means that the possibility for premium pricing increases. From that perspective, it's a positive result to understand the medicine and which patients it will benefit. Thank you. Another question is: Have any companies shown interest or contacted you after CORIST part one? Now that we are in the 12- 18 month period to strike a deal, can you develop more on what kind of deals Scandion Oncology is looking for? There is, again, a couple of things in the question. We are working in all lines of the company, meaning our pre-clinical R&D, our clinical R&D, and obviously also in business development. All I can say is that everyone around me has a full-time endeavor or job in doing that. We are being active in pursuing what gives the best value for the company and our shareholders. Thank you. Another question: Are you running any collaboration with academia at this time, or do you have any plans in the near future? We are, as a biotech company of the size that we have, aware of the strength in collaborations and we have activities also with academia. There is nothing specific in the question here. As a general, I would say yes. We will continue to be active and engaging into collaborations. Thank you. Another question: Can we expect more hirings in any key positions going forward? The plan here is building a company to last. We are focused also on the long-term value. I would say in order to deliver on that promise and live that dream, I would expect that the company would, in the future, continue also to hire competencies as needed for the right positions and in order to actually build the company to a successful and valuable larger company in the future. Thank you. With that, there are no further questions on topics that have not already been covered. Okay. That concludes the session, and I thank you all for your attention and for listening in here. Have a very nice day.
Loading workspace