Yes. Good morning. My name is Bo Rode Hansen, I'm the CEO of Scandion Oncology, I'm here with Carit Andersen, the company's CFO. I'm going to take you through our Q1 2021 Interim Report in the next 10- 12 minutes. Next slide, please. First, a disclaimer as we will be bringing forward-looking statements. Next slide. What I'm going to take you through today is outlined on the agenda. We'll touch on the highlights from the first quarter of this year and touch on our engine room in terms of the clinical pipeline. We'll also go into financial update for the quarter then give you a little bit of a perspective on the outlook for what we are expecting in 2021 and why Scandion Oncology is an important company to consider in terms of investments. Finally, we'll talk a little bit about our upcoming events. Next slide, please. Let's look at the highlights from the first quarter of the year. Q1 2021, we had a couple of important announcements. First of all, we started out the year with a transition into Nasdaq First North, a growth market in Stockholm. Then we also announced on the first 12 patients in our ongoing CORIST study. We also announced that we were using the data to amend our PANTAX study, which is second clinical trial. The quarter has focused very much on building and strengthening the team, which is very important in order to transform science into medicines and thereby into value for shareholders and patients. Then I was also very pleased to announce that we have strengthened both the team internally but also our advisors by bringing an international renowned individual, Richard L. Schilsky, who's a professor and a doctor, into our clinical advisory board. He's a former ASCO executive. Next slide, please. If we look a bit at Richard's commitment to this important mission that we are on in Scandion Oncology, really making a difference for the many patients struggling with resistant tumors. Richard is really agreeing to that this is a mission that is of major importance, it's clear and important, and it's a very strong unmet medical need that Scandion Oncology is pursuing here. Next slide, please. Let's take a quick look at the engine room of Scandion Oncology. We have both progress to our pipeline and our clinical pipeline is really focusing on developing a first-in-class medicine, which eventually is aiming at personalized therapy. SCO-101, our most advanced asset, is unique in the sense that it targets an otherwise unaddressed mechanism. There are no drugs on the market today reverting cancer drug resistance, and we have this in the two ongoing trials, CORIST and PANTAX. I want to say that clinical development is an important piece of the value creation in a company like Scandion Oncology. Our CORIST trial is currently training towards the end of the first part of the study, and we have committed to reporting on data from this first part in Q2 of this year, so this quarter, and we will continue into an effect arm. The first part is focused on safety, tolerability and also the science effect that we can see. Our second trial, PANTAX, is in the pancreatic cancer, where we're testing SCO-101 in combination with nab-paclitaxel and gemcitabine. Finally, we are focused on biomarker development such that we can find predictive biomarkers and validate them in order to strengthen our clinical trials. We have already, in CORIST, announced that the first 12 patients in the cohort were finalized, that gave us the green light to continue into the next cohort. We use those data also to amend our PANTAX study in order to put it at the best position. Now we are expecting to read out in the second quarter from our CORIST trial on the first part, then we will then, based on those data, continue into the phase II and the second part of this trial. Our PANTAX data are expected to read out from the phase I-B that we are conducting in Q3, Q4 of this year. It is important to say that when it comes to clinical trials, it's important to have all the data in order to conclude and in order to make the best possible continuation and value creation for both patients and shareholders. Next slide. Here I'll pass the word to Carit, who will take us through the numbers for the quarter. Thank you, Bo. Good morning, everyone. I'm Carit Andersen. I'm CFO of Scandion Oncology. Next slide, please. Key figures and highlights for the Q1 2021 is first of all. Our loss before financial items, EBIT it's called, is for the quarter, a little less than DKK 10 million, which compares to just DKK 4 million as loss in Q1 in 2020, a year ago. Compared with 2020, where we had DKK 23 million in loss, the loss in Q1 2021 is, of course, relatively higher than previous quarters. In terms of our strong cash position end of March 2021, we have DKK 145 million in cash, which compares to just DKK 11 million in cash end of Q1 2020. End of 2020, we had just DKK 6 million in cash position. Next slide, please. If we look at the development from loss of DKK 4 million in Q1 2020 and up to the DKK 10 million in loss in Q1 2021, there are two things that explains that increase in loss. It's equally important explanations. The first explanation is that there's an increase in the external expenses of around DKK 3 million from the Q1 2020 to the Q1 2021. External expenses is subcontractors like a clinical research organization that are used when we do the clinical trials at the hospital sites and the expert consultants and the like. The DKK 3 million is driven very much by the increased effort in our clinical trials, the CORIST study that has been intensified and the PANTAX study that has been initiated between the Q1 2020 and the Q1 2021. The second explanation is also almost an increase of 3 million when we compare Q1 2020 with Q1 2021. That is the increase in staff cost. That comes from the fact that we were starting out as a more virtual-like company, and we're now moving and have moved into a more solid and advanced clinical stage company where we have a regular staff hired into the company. Next slide, please. As mentioned, we have a strong cash position, 145 million in cash end of Q1 2021. The monthly cash burn for the first quarter is per month, a little more than DKK 2.2 million. It means that we are financed up until at least after 2022, meaning that we have funds into 2023. If we look at the operating expenses over the quarters in 2019, 2020, and the first quarter of 2021, the trend is an increase in operating expenses. That increase will continue over the next months and quarters, ending up at a higher level than what we have seen historically. The reason for that is, of course, that Scandion is actually developing rapidly to be able to strengthen and to be able to maximize the value creation in the company. Next slide, please. To look a little bit at what you can expect, I've already mentioned that our metastatic colorectal cancer trial, CORIST, with SCO-101 together with FOLFIRI, is reading out from the first part here in the second quarter of this year, and we expect to keep that timeline. We also expect to initiate the second part of that trial. Another important event is more in the preclinical space where we are establishing SCO-101 as a potential component in immuno-oncology. This is also a collaboration with Alligator Bioscience, where we expect the first signs of data in this quarter. Then we are looking forward to learning from our PANTAX trial in the phase I-B in the range of Q3, Q4, and thereby use that as basis for initiation of a randomized study, a phase II study in PANTAX. Finally, our financing takes us according to our prospectus and according to our plans, through to the end of 2022 and into 2023. Finally, next slide, let's look at if you take sort of three points of why to invest in Scandion Oncology. We're targeting a major unmet need, cancer drug resistance. We have a first-in-class drug. There are no drugs on the market. This is a very large unmet need, thereby, unfortunately, a very large market also of chemotherapy that we would tap directly into. Our drug is targeting well-documented mechanisms of action. The science behind is known. We already have two ongoing clinical trials, CORIST and PANTAX. Finally, we are building the company and the team for evolving this to the next level in order to create value for shareholders and patients. Next slide, please. Just a few remarks on where you can meet us next. We have our annual general meeting coming up May 26th, and we also have a presentation on Redeye Growth Day on June 2nd. Then our financial calendar is presented here with our half-year report coming out August 19th, our Q3 report scheduled for November 18th, and then into next year, we expect to deliver our year-end report on February 17th. Next slide, please. This then concludes the presentation of our Q1 Interim Report and my presentation. Now we will open the floor for a Q&A session. First, I want to answer a couple of questions. There's been a lot of good shareholder interaction, and I've received a number of questions beforehand. In order to address a couple of those, I just want to start out with a couple of questions that is relating to what I just mentioned in our upcoming events, our scheduled AGM for May 26th. The first one is a question relating to one of the things that we have in our AGM notice is that we are asking for approval to carry out the capital increase of 30%. There's been a number of questions to why this is necessary now and so on. I just want to address here that we are a Danish company, so a Danish A/S, which is listed in the Swedish capital market, and that gives a couple of considerations. There are some differences between Denmark and Sweden in that way in relation to how much is customary and how much is accepted in terms of share discounts and what is expected from the capital market. One of the reasons that we are asking for this, you can say, fairly substantial capital increase of up to 30%, is to have an authorization that reaches out way into the future for the company to constantly trim and optimize its capital position and to work on the capital strategy. We know that it's common in Sweden to ask for maybe 10% or 20% per year, but this is a long-term proposal that gives us the ability, if and when the time is right, to bring in a or a couple of institutional investors through a directed issue into the share book. This is not intended for any special purpose right now. We don't have any specific investor standing in the corridor, and it does not mean that we are needing additional cash to what we have communicated on beforehand. This is just to give the company, and a wish from the board, to position the company in the strongest possible position to navigate the capital market. I want to underscore that in conclusion, I will highlight that we are well-funded, as I just said, through all of 2022 into 2023. Another question that I've received numerous emails around and that I have also committed to addressing at this call today is another point from our upcoming annual general meeting, and that is our board has asked for an authorization from the shareholders to issue warrants. I can understand that the component of warrants just needs a few remarks. First of all, the reason why we bring this on the AGM is simply because that's the right place to ask shareholders for authorization. The warrants are an instrument that the board would like in order to have the right remuneration tools for bringing on board and retaining the right individuals that are part of the value creation. This is the way our industry works. We are in a global market, so we need to be globally competitive. Scandion is not only competing locally for talents, but on the global market. It's intended to have warrants at hand that can be committed if and when we have discussions with the right individuals that can help Scandion in the journey on becoming the cancer drug resistance company and creating value. That's the reason for asking for the warrants. We need to attract the best. What I want to say here is that it's also obvious for me and for the board of directors that no warrants will be issued before we have readout of what we have committed to in Q2. Let me be clear. No warrants will be issued to anyone before we have CORIST readout and also the other readouts that we have committed to in Q2. I think that sort of concludes it for the many questions that I have received up to this call. Now operator, please, if we can open the line for additional questions, I'll be happy to answer them at my desk. Thank you. If you do wish to ask a question, please press zero one on your telephone keypad now. If you wish to withdraw your question, you may do so by pressing zero two to cancel. There will be a brief pause while questions are being registered. Our first question comes from the line of Christian Binder from Redeye. Please go ahead. Your line is now open. Thank you so much for taking my questions. I have several, if that's okay. Starting with CORIST, one of the primary outcome measures is objective response rate. Looking at the second cohort, the efficacy arm, can you make any statements about what objective response rate you would like to see to consider a trial successful? Hello, Christian, and thanks for the question. Yes, the way the trial has been set up, it is like this, that a single patient showing an objective response is enough to expand the trial with an additional 10 patients. You can say the objective response rate is if we see that one patient has an objective response, we will expand the trial with 10 patients, and then we can then be looking for one additional objective response. All right. Thank you very much. My second question regarding EndoRIST. In a scenario where that program would enter the clinic in 2022, would that affect any of the statements that you've made about your funding runway, or does it still hold that you expect your funding to suffice until 2023? Thanks for the question on EndoRIST. If we take a step back here, as I said, what I've shown in our pipeline slide is what we have committed to in our prospectus. This is where we raised the funds that we have raised recently. In terms of EndoRIST, we are evaluating, and with rigor, evaluating the preclinical data in order to understand both the market dimension and the science of this opportunity. When that is concluded, we would be likely to move forward on the EndoRIST if this conclusion, if this analysis is positive. In that instance, we do have funds for the very early parts of that, but it's not included in what we have raised funds for in our prospectus. All right. Thank you very much. Last question. You've recently made several hires, and also in the CEO letter, you mentioned that you plan to continue building the organization. Can you make any statements about what areas you intend to make further hires in? Yes. In terms of bringing, you can say, more people and the right people on the bus, we intend to continue our journey towards becoming the cancer drug resistance company. Hires are planned both in the general administration of the company in order to have the backbone in place. We will be very cost-conscious and lean, and I think you can see that the company has a track record based on our spend of being that. Obviously also in R&D, where we will strengthen the company in terms of medical oncology, in terms of R&D. I think your question just tails over to my earlier comment on why it's also important to have the instruments at hand at the board level in order to attract and retain the right individuals for transforming value here. Creating value. All right. That was all of my questions. Thank you. Thank you. Ladies and gentlemen, once again, I remind you, if you do wish to ask a question, please press zero one on your telephone keypad now. We currently have no further questions. I will hand back to the speakers for any further remarks. Kate? Yes. We have received some questions in writing during the presentation. I can read the first one. It says: [No break] that no warrants are issued before readout, but the plan states that they will be priced 10 days off AGM. The price will still reflect the price pre-readout? Okay. That's a very good question, and let me clarify here that the way that these warrants work in terms of pricing is that it's at the time of grant that this pricing period starts. This means that as I just stated, and I will again restate, there will be no warrants granted issued before we have reported on our ongoing CORIST study in part 1. That means that there will be no pricing immediately after AGM unless the data from CORIST have been reported at that point. Thank you. We have another question here. It says, "If you see a good effect in the first part of CORIST, can we expect a randomized second part? The question is relative to whether we want to change tactics in the already ongoing phase II trial. I think that I understand where the question is coming from, but this trial is a phase II trial with a dose-finding phase as part 1, which has primary objectives on safety tolerability and also effect, and then it's transitioning straight into the effect arm. A change into a randomized trial would require that we significantly changed and amended the trial. There's another component to it. Here we are addressing a third-line failure population, so there's no real good control arm to put this against. In order to design a randomized trial, we would have to go in a completely different setup. The answer to that question is that we don't have any plans to do that. Are there any more questions online? Thank you. We currently have no further questions registered on the audio. Okay, there's another one here from the email. Yes. We have a question here, "Will we get any update on SOM-001 this year? There's a question around SOM-001, which is a very early-stage program in the microbiology space. Just to repeat what I've stated earlier, SOM-001 is not within our sort of core focus or core strategy. We are, Scandion Oncology, focused on cancer drug resistance. What we committed to was to see if we could compile a data package which was strong enough to meet the commercial criteria expected from entities or companies interested in this space. At the point where we are, this has not been fruitful. We do have some data. They're not strong enough. We have tested and vetted them with different commercial entities. From that perspective, we have decided to focus on oncology and focus our efforts on creating medicines for cancer drug resistance and thereby creating the best value for our shareholders and the patients in need. Thank you. We have received another question. It says, "If you look into the Nasdaq- listed company ORIC, the valuation of this company is 15 times higher. Do you think that reflects a 15 times bigger pipeline, or do you think this is due to listing of Nasdaq? If you had any comments about listing Scandion to Nasdaq U.S.? I think that from a perspective of this being a very interesting question, the valuation of ORIC and valuation of Scandion, in essence, I leave it to the shareholders and the market around that. I do see some common traits between the companies. We are both in the space of cancer drug resistance. I think we have different approaches, and we have a unique approach that I believe very strongly in. I think that also if you look to some external analysis for this field, others have also picked up ORIC and Scandion as peers. I think that is fair. That's as much as I would say to this question, and I'm happy to take the next one. Okay. We have another one here. It says, "Last year you said that it's not unrealistic to try to deal within 12-18 months. Now when we're approaching this timeframe, are you still considering it possible? Yes. I think that's another important question that, if we again look at what has been in the history of Scandion? Where are we? What are we positioning? I think that in terms of striking a deal, if that is the objective, one could always strike a deal. It's about striking the right and the best deal, again, from the objective of delivering and maximizing the value for shareholders and taking the company forward in the right fashion. At this point in time, I think that any conversation, and I know this from many years in the industry and also being on the other side, what is important is to have strong validating data. We are focusing on bringing our programs forward and positioning them in the right way in terms of market and the way we strategically position them. I would say, instead of timing a deal, I would rather say the deal needs to be the right deal in order for us to really consider it. Thank you. I think we have another question here in relation to what you talked about with the warrants. It says something. I don't know if a further explanation is needed. The question is the suggestion for 10 days VWAP after AGM. Final changes suggestion to 10 days of the AGM or date of readout, the later of the two. Well, I don't have that information right in front of me. I think what I can say here is just to repeat what I said, that the intent with the warrant program is to be competitive in an international market where we wish to attract and retain the right competencies and develop the company through that source. There is no intent to issue any warrants prior to the readout of CORIST. If I may add to the discussion on the pricing of the warrants that might be granted over the next couple of years, depending on decisions by the board of directors, it is the subscription price of these warrants that will be set on an average of 10 days after the date where the warrants are granted, as Bo mentioned earlier on. If some of these warrants are granted, say, beginning of 2022, then at that time, they will reflect the share price that might be at that point of time. The authorization of these warrants is for a five-year period, so they might be granted earlier, or they might be granted later on in the period, or they might not be granted at all. It's an authorization to the board. Thank you. Yeah. Thanks for detailing that. We have another question. Why has Scandion decreased communication with shareholders in the last eight months? I think that this is a question where we have to agree on the premise. I don't know in what dimension we have decreased communication. Let me make one thing very clear. Scandion Oncology is a clinical stage biotech company focused on developing a very novel approach into a very big unmet medical need. This is the primary focus for the company, and to do that, we obviously need capital resources, and we need to be in close contact and create and de-risk the investment. In that case, we are focusing on a shareholder communication that gives the best possibility for de-risking and understanding the investment that has been made here and try to avoid to send too many, you can say, noisy signals into this system. This is maybe a change to what has been experienced in the past, but it's also important to understand the clinical development is sort of an endurance sport where you can't give split times all the time. You can't sort of look in patient by patient. You need to get to a point where there's a clear conclusion in order to give a fair assessment of where the company is at and where the clinical development program is at in order to give the shareholders the best view on how to evaluate and de-risk their investment. This is from the basis that we are laying out our communication tactics. I will also say that from a personal perspective, it would be very nice for me to be sort of in live mode. It has been hampered a bit by the ongoing situation, health care crisis around the pandemic, not to be able to go out there and meet more shareholders. This is definitely something that we will try to increase from the company as much as possible. Thank you. We have another question. How many patients are going to report on from CORIST phase II, part 1? It says on the homepage 12-18 patients. Yes. I think that is also a fair question, which I'm not going to detail today anything from our CORIST study. I will leave that for the study to complete and read out, and we're not going to comment right now on the number of patients. Thank you. We have another comment in relation to the warrant. It says here, "Now you clarified that warrants are not going to be priced before data release. Can we get that in writing for the coming AGM Friday? I think that in that sense, what kind of documentation do you need? We asked for an authorization, our board asked for an authorization to be able to have this instrument in a forward-looking fashion. I think I made myself very clear. We will not, this is obviously also in full line with our board. If we should have anything, we should have our board issue a written statement on this. I can tell you that we are not going to issue any warrants prior to a readout from the part 1 of our CORIST. Thank you. A question here. "Seeing analysis from Redeye, is that the only analysis we will see this year? I think that the first thing, it is good that we have sort of external analysis looking at Scandion Oncology. I think that Redeye has done a thorough job on the first analysis on the company here that has been published. In terms of further analysis, I would welcome that. This is a starting point, but I expect in the future to see more analysis and more analysts following Scandion. Yes. Here is a question, "Would it be possible to elaborate on what changes in the results in CORIST led you in relation to the PANTAX protocol? I can only refer to what has been stated previously, that we concluded the first 12-patient cohort in CORIST and used those data to make sure that our PANTAX trial was fitted to the maximum of obtaining results in that trial. Another question in relationship to PANTAX exactly. "Can you give any update on PANTAX? How is enrollment going and if I may ask, will much more patients be involved internationally? I think that from a slightly wider perspective, as I said earlier in this call, we strive to have our shareholder communication as precise and quality-based and with the ability to de-risk. We will not inform sort of in real time on progress in the ongoing clinical trials. We want to get to a point where we can draw some clear conclusions in all fairness. I would say on the latter part of the question, we have already announced that we are looking internationally in terms of patient recruitment and opening sites outside Denmark. There is another question in relation to EndoRIST. It says, "Have you decided on the study start for EndoRIST in Q4 2021 still valid? Yes. Again, this is going back to an interesting question we got earlier. EndoRIST is, in terms of our current perspectives, not part of the funds that we raised recently. For that reason, we are considering carefully whether EndoRIST has the profile, the data, and the market potential that we expect in order to consider whether this is added value. This analysis is still ongoing, and we have no current definitive plans on entry of EndoRIST into the clinic in Q4. Thank you. We have another question here. "You've made several very impressive recruitment-related announcements because they expect to report some studies that could prove an inflection point for the company. Would that not be an unwise thing to do if you were not expecting good results? Well, it's definitely true that we have recruited a couple of capacities within the pharmaceutical and life science space. Again, I think that these individuals obviously buy into the vision and the commitment of creating the cancer drug resistance company and have also considered carefully before joining the company, obviously. I think it's a holistic picture of what brings people to workplaces. It's culture, it's determination, it's the mission. On all those accounts, it is important also to say that, again, going back to our previous questions around having instruments in place in order to compete in the global market, it is important that we stay focused on continuing to bring and retain the right people to the company in order to transform science into value and into benefits for patients. Thank you. We have one question, again, in relation to the warrants they're asking, how does this change in definition of new warrants, the change affect our votes? The proposal is still the same in the voting system. I'm not sure if I understood that question correctly, but if it's relative to how to vote on the AGM, Carit, do you want to say anything about the technicalities here on voting? Yeah, sure. The warrants in itself do not carry any types of votes. If and when they are exercised, the warrants that might be handed out, they turn into shares. Of course, these shares, they have equal rights compared to existing shares. There will be more shares and each share carries one vote, whether they are coming from share issues or from employee warrants as discussed here. Okay. I think that was a quite substantial Q&A. I want to thank you all for the interest and the many good questions. Thank you, operator. I hope this call has been clarifying. I want to sort of close out by saying that we want to be open and transparent about our business, but also hope that there is an understanding and appreciation that we cannot answer your questions sort of continuously. We want to focus on the work that lies ahead. We want to focus on the mission that Scandion is on and make sure that our clinical development of SCO-101 and the coming compounds on our pipeline will have the best attention. To all shareholders, I want to say that I look forward to seeing you again. First chance is the upcoming AGM on Wednesday next week. To everyone, I want to wish you a very nice day and say goodbye for now. Thank you.
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