Welcome to Scandion Oncology Q1 Report 2024. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing pound key five on the telephone keypad. Now I will hand the conference over to CEO François Martelet and CFO Johnny Stilou. Please go ahead. Thank you very much, and, welcome to this, Q1 2024 conference call, in which we will be reporting our progress, of the last, quarter. Next slide, please. So this is a disclaimer slide that I will not ask you to read, obviously. Next slide, please. So today I will go through the, CORIST overview and our results. I will also have, some remarks about the PANTAX final data, and then Johnny will address the financial performance of, the company. And then I will, making some closing remarks, summarizing where we stand and where we will be as a company. Next slide, please. So before I will go into the CORIST overview and review, I just would like to mention again that we are at Scandion very small team of very senior level executives, having all of us a lot of experience in biopharma, in pharma, and in biotechnology. And then I would like to mention that we have a very strong clinical advisory board, especially Professor Tabernero. Some of you may have watched the interview that he gave us during the R&D day we just had a few days ago in in Stockholm, that was broadcasted as well. So I would like also to mention that we have added two leading oncologists, Professor Per Pfeiffer from Copenhagen and Professor Michel Ducreux from Paris. Both are really leading European clinical oncologists in the field of GI, gastrointestinal, diseases. And therefore, we are very well equipped to be advised on any future design of our clinical trial, and also on our, and I will come back to that, what we call CORIST Next Step. Next slide, please. So this is a slide that shows you the overview of our pipeline, and I would like to mention, so SCO-101, which is our lead compound, that most of you know is addressed in colorectal cancer and pancreatic cancer, not mentioning gastric cancer as well. I would like to spend just one minute on SCO-201. SCO-201 is our follow-up compound and is currently on hold from a development perspective, not because it is a bad compound, but because we need to make some prioritization. That compound may be studied further in HIV/solid tumors. So to come back on SCO-101, so you see the CORIST data. You see that we will be releasing the final data of the CORIST Part 3 in H2 2024. With regard to PANTAX, some of you have noticed that we have released the H1, the final data a few days ago, actually, and I will come back to that as well. Not mentioning again, you know, gastric cancer is, we have a good preclinical data in gastric, and we are what we call 1b/2a ready. So this is the pipeline that fundamentally consists of our lead compound, you know, SCO-101. Next slide, please. So this is the results of the CORIST Part 3, and I would like you to spend a little bit of attention to that. So on the CORIST Part 3, we have observed, out of six patients, two partial responses, meaning that the tumor shrinkage or the tumor reduction was more than 30%. And this is actually quite outstanding in by all metrics in last-line colorectal cancer patients. It's if you compare that number to a recent study, then you will have a 6% as a tumor reduction. Of course, you know, these results, our results, need to be confirmed in a randomized clinical trial. But at least, you know, no one can argue about we have had very good sign of clinical efficacy. At the same time, we had a CBR, so clinical benefit rate, of 76% after 8 weeks. And, if you compare to another study that has been reported, I mean, the data is very good. Even more importantly, we have a promising medium overall survival close to eight months and a medium progression-free survival of about 3.8 months. If you compare this PFS, progression-free survival, with another study that has been recently released, then you get to the number of, less than two months. So again, no one can argue that we haven't had released good data. We are really, the company in drug resistance, showing some significant data out of this Phase IIa. And then finally-... Because we all know that the regulatory authorities will never accept any clinical development without a significant biomarker, we have been able to identify a biomarker for our next step and down the road randomized clinical trial called UGT1A1. And if we select with this UGT1A1 biomarker, wild type patients with colorectal cancer, then you get to a median overall survival, even better, even longer, of close to actually 14 months. And again, if you compare to a recent study, yes, with many more patients, but still you get only close to 11 months. So we have really good signs of clinical efficacy that I would like to also show you to the next slide. And this is a very important slide, and I couldn't resist to show it to you. You know, this is a 55-year-old female with a RAS mutated colon cancer patient that we have been treated in from August 2023. She's still alive. On the left-hand side, you could see when we started the treatment. So you could see the tumor on the scan, quite a large one. Then after, from August until December, you could see the very significant tumor shrinkage of the tumor. That patient is still alive. That patient has a partial response. So this is what I wanted to show you as an example of our clinical efficacy. Now, furthermore, it's important to notice that the other patients, it had also a tumor shrinkage, but with a less magnitude, so between 6% and 25%, and not to the 30%, which is a threshold, but still, we had tumor reduction. Next slide, please. So if I could summarize very quickly the CORIST Part 1, Part 2, and Part 3, we could easily say we have a good safety and a good tolerability profile. The partial responses in two patients in the last cohort of the six patients, with a dosage of 250 milligrams, with a four-day schedule, we have an impressive overall survival between eight months and 10 months. We have a significant increase in overall survival in a subgroup of patients expressing wild type UGT1A1 from 8 months to more than 13 months. And then, you know, what does that mean? That means that this data does justify the expansion of our CORIST part three, and we need to have a small patient cohort in order to look at the maximum tolerated dose and look at the dosing regimen. So that will be further applied in a randomized clinical trial. Yes, next slide will show you the data that we have released recently with regard to pancreatic cancer, PANTAX Phase Ib. The maximum tolerated dose achieved is 200 milligrams of SCO-101. The PK data demonstrated that SCO-101 exposure is in line with our expectations. We had a partial response, and we had an overall response rate of 6.7% with a good CBR. Progression-free survival was 2.5 months. Overall survival was 9.5 months. I have to say that, these results are pretty good. If we don't pursue the clinical development of pancreatic cancer, it's not because we get bad data, it's because that we need to prioritize even our relatively small level of resources, need to prioritize onto colorectal cancer. And having said that, I will now pass the word to our dear CFO. Johnny, the floor is yours. Thank you, François. If you look at this slide with the financial overview, you can see that the results of the quarter was a net loss of DKK 7.5 million. This compares to a loss of DKK 9.3 million in the previous Q1 quarter of last year, 2023. The quarter ended with a cash position of DKK 16.9 million. Overall, the result is in line with our expectations, and once again, it reflects our continued focus on reducing our costs. If we look at the next slide, at the bottom, you can see the past eight quarters, how our overall cost base have declined. The Q1 2024 is the lowest quarterly cost we have had, and we do expect, as our clinical programs progress and our continued focus, that our quarterly cost base will continue to be reduced over the coming quarters. With that in mind, our current funds can fund operations into Q2 of 2025 as a going concern. Now, I will just quickly give you an update on the ongoing rights issue, some important dates here. As you, we've shown this a couple of times. The subscription price period, we are in the middle of that now, and it runs until tomorrow, May 23rd. Following that tomorrow, we will publish the final terms of the rights issue. Around June 3rd, the prospectus will be made public, following which the trading and subscription period starts. In the period between June 5 to June 17th, you can trade in the unit rights through your, through your bank. In the same period, plus three days, so from June 5 to June 20th, the subscription period is open, where you can subscribe for the shares in the rights issue. Again, this you can do through your bank. Thank you. With that, I will give the word back to François for closing remarks. Thank you, Johnny. So this slide does show you what you can expect from Scandion during the second part of the year, as we are approaching H2. So first of all, we will be releasing the final CORIST data part three, and that's an important data release that will happen before year end. And then we will be releasing the top line of the CORIST next step. You see, this is the small study that we will embark on following the successful completion of the rights issue, and we expect to release that around year end, so it could be slightly before or slightly after. Next slide, please. So to summarize, I would like to mention that on the corporate side, we will certainly continue to maximize our runway, as Johnny mentioned. We will continue to reap the benefits of our change of communication with regard to the paradigm of our technology. We are a drug efflux pump inhibition company, and this is very important. We are not a chemotherapy company or generic company. We are an efflux pump inhibition company. We will be therefore increasing the focus on presentation to investors, to potential partners, as we have been starting quite some time ago. And then, obviously, by executing this little bridge study that will determine the MTD and strengthen the data package, we will be in a far better position to find a partner. On the scientific and medical side, as it was mentioned before, I just would like to add that we have been scheduling a global scientific advisory board in colorectal cancer. We had one in December, where we will repeat that one with US investigators this time. And also, we will be preparing the randomized Phase IIb/Phase III colorectal cancer. So next slide, to summarize our strengths. We are a precision anticancer drug company. We are one of the first company addressing drug resistance in oncology. We have this dual mechanism of action that I didn't remind to some of you because it has been mentioned before, targeting ABCG2 and UGT1A1. And certainly, we are one of the first movers in targeting cancer drug resistance. Needless to say that colorectal cancer is a deadly disease at the survival rate at five years at metastatic stage is about 12%. Unfortunately, when this diagnosis is done, most, most the majority of the patients, more than 60% of the patients are already in a metastatic stage. So there is obviously a great, market potential for, this, for our drug in this particular market. Johnny mentioned that we will be continuing to maximize the runway by controlling quite drastically our cost, which is the obsession of a good CFO and of a good CEO, I think, in biotech. As you see, we are very strongly focused. We will be dedicating our resources to the CORIST next step. We, I hope I was able to demonstrate that we are a very small team of very senior executives, and we are helped and assisted by the best-in-class, by all standards, clinical advisory boards, as I mentioned before earlier in my presentation. Value inflection point, I mentioned that CORIST next step study and the final CORIST Part 3 results. Now, having said that, I would like to thank you for your trust and commitment, for your patience as well, as we are today in the most favorable position in the history of Scandion. Having said that, thank you very much, and back to the operator now for Q&A. Thank you. The first question comes from the line of Christian Binder from Redeye. Please go ahead. Your line is open. Hi, and thank you so much for taking my questions. I have two, if that's okay. First off, you already showed, you know, this timeline in terms of when you're gonna have the Part 3 expansion cohort top line data, and you mentioned that it could vary by a couple of months. But I guess depending on when the readout comes, it's not necessarily gonna affect your timeline for the Phase IIb, Phase III or... Can you elaborate on how the readout is gonna affect the timeline for the coming trial? ... Yeah, no, certainly, and thank you for asking this question. Well, you know, as I said earlier, you know, we will be embarking as soon as the rights issue is successfully completed on this bridge study that will be looking at MTD and looking at in order to strengthen our package as well. We will be also looking at PRs, you see. And obviously, once this is on, and I said around year end, we will get the top line result. But at the same time, you know, we need to wait a bit of time to be able to get the overall survival. So would that influence the sort of the CRC Phase IIb/Phase III? Probably not. But the fundamental question is that we need a partner in order to perform that study. Absolutely, given the magnitude of the size of it. If you compare to what has been published recently in the literature, we are talking about 500 patients, 600 patients, 700 patients. All right. Perfect. That's very helpful. And my other question would be, if I understood it correctly, about 50% of your rights issue is guaranteed. In case you come close to around 100% subscription, is that gonna affect the timeline for the Phase IIb, in terms of preparations and other activities? Correctly stated that 50%, around 50% is a guarantee. If we get a subscription higher than the 50%, that will not enable us to start the Phase II randomized studies. However, it will extend our runway, and it will enable us to start the preparations needed for the phase IIb study. All right. Perfect. That was all from my side. Thank you so much. Thank you. There are no more questions from the teleconference, so I hand the word back to François and Johnny for any closing comments. Thank you very much. So, so I hope, you know, we were able to show you today that we are indeed in the most favorable position in the history of Scandion, given the kind of the data we've been able to release, and we look forward to complete the rights issue and to start as soon as possible our little small bridge study. Thank you so much again, and speak to you soon. Thanks for your participation. This concludes today's call. You may disconnect your lines.
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