...Welcome to Scandion Oncology Q2 report twenty twenty-four. During the questions and answer session, participants on the teleconference are able to ask questions by dialing pound key five on the telephone keypad. Today's report will be presented by CEO François Martelet and CFO Johnny Stilou. Now, I will hand the conference over to CEO François Martelet. Please go ahead. Thank you very much, and welcome again to this Q2 twenty twenty-four report. Next slide, please. Right, so this is a disclaimer that we'll not go through. Next one. All right, so today we will go through the CORIST data. Basically, we will go through the performance. This will be done by our CFO, Johnny. And then I will end this call with the near-term milestones of Scandion Oncology. Right. Shall we have the next slide, please? Right. So today the speaker, as I said earlier, is myself as the CEO and Johnny, our CFO. Next slide. Right. So today is an important call, and the reason being that we have fully enrolled our patients into the CORIST trial. Furthermore, we have also achieved MTD, and consequently, we are in a process to finally analyze the full set of data of our CORIST clinical trial. So that's an important milestone that we have achieved at Scandion Oncology over the last few months, and I will come back to that. With regard to PANTAX, we have released the data actually earlier this year. And with regard to gastric, we have also released very good pre-clinical data, and we are ready for moving ahead in phase Ib/IIa. With regard to our other asset, which is SCO-201, we have decided mainly for financial constraints to hold the further development on from a preclinical perspective of this compound. Doesn't mean that there is no potential, it means that we have decided to put this the development of this compound on hold. Right. So let's move to the next slide, please. Right, so with regard to the CORIST part three, what have we basically achieved? The last cohort has certainly shown a significant tumor reduction, tumor shrinkage, which is defined as more than 30% tumor shrinkage. That was observed in a limited number of patients, actually, two out of six, who have been treated with a four-day schedule using FOLFIRI, and we have using the dose of 250 milligrams of SCO-101. The tumor reduction in a recent study was actually, you know, much, much less, if you look at the percentage. Of course, we are working with a limited number of patients. However, the tumor shrinkage that we have observed is significant. We have had also an exciting clinical benefit rate of 76% after eight weeks. If you look at historical control, basically, you know, we are talking about 11-16%. Again, this is a limited number of patients, a limited cohort. However, we believe that there is some significance here. In CORIST part two, we had a clinical benefit rate, which was less significant around 42%. Even more important, we have a promising median overall survival close to eight months, and a median progression-free survival around four months. Obviously, we are waiting for further data to mature. This is a classical case in oncology, and we do expect to have even better data in a couple of months from now. Also, if we look at historical studies comparing median overall survival and median progression-free survival, we are able to show some better data. Another important point is the biomarker. So we've been able to identify UGT1A1 as a potential biomarker, especially with the wild-type colorectal cancer patients. And this is certainly an important aspect for future developments. Because as we know, that the regulatory bodies, you know, now require a biomarker in order to better stratify the patients, in order to potentially get an approval, talking about the FDA mainly, but also in Europe. Right. Shall we move to the next slide, please? Right. If we could summarize what we have done over the last few months and even years with regard to CORIST, we've been able to demonstrate a good safety and a good tolerability profile for our drug, SCO-101. We have been able to show some partial responses in two patients in the last cohort of six patients, with some significant and impressive overall survival, close to between eight and 10 months. That significant increase in overall survival is even better, is even enhanced if we look at patients expressing wild-type UGT1A1 colorectal cancer patients. We are moving up to 13 months. Right, and the last progress that we have been able to show over the last quarter is actually the MTD. So we've been able to show an MTD for the four-day schedule of our compound SCO-101, combined with FOLFIRI at a 50% irinotecan dosage and 100% leucovorin and 5-FU, demonstrating that we have obviously a very active drug. So overall, you know, if I could summarize the data set of CORIST part one, two, three, the data is very encouraging. We have an active drug, and therefore, we believe it will be extremely worthwhile to continue the development of this drug in future settings. Meaning, and I will come back to that, phase IIb/III, potentially. Right. Next slide, please. Okay, Johnny, would you take over, please? Yes, certainly, and thank you, François. Here, yes, we state our result in the quarter was in line with our expectations. The quarter showed a loss of DKK 7.1 million. This is compared to a loss of DKK 8.7 million in the same quarter of last year. Our cash position in June showed a position of DKK 26.9 million. This reflects the completed rights issue in June, which gave us net proceeds of DKK 14.3 million. With these funds in total, our operations are fully funded into Q4 of 2025. On the next slide, as shown here, our quarterly expenses once again are reduced compared to the previous quarter. Our quarterly cost will continue to decrease throughout 2024 and also 2025, as a result of our very strict cost control. With this, I will give the word back to François. Thank you, Johnny, and thank you for your good cash management. Right. So, let's look at the near-term milestones. So if you look at the top of the slide, so you see that we are expecting to release data from the CORIST part three later during the year, regarding overall survival and median progression-free survival. You know, that we have reached recently at our MTD. This is what I call the CORIST next step, and this is materialized by the blue arrow, which is, of course, a very important aspect in our clinical development program. Now we have a dose, we have a schedule, and then we can move forward. Now, with regard to the, let's say, the final results of the CORIST next step, we do expect them not before H1 2025, because, again, we need the data to mature, we need to give a chance, you know, basically to those patients, and some of them are still surviving, you know. Therefore, we do expect to release some good overall survival data. Now, next step. Next step would be a randomized clinical trial, either a phase two B and/or a phase three directly, and for that purpose, we need to have a partner. We are too small company in order to embark on such a journey, so we need to have more financial muscles in order to do it, and that's the reason why you have seen, I'm sure, the press release that relates to the appointment of Back Bay Life Science Advisors as a boutique financial firm in order to find a partner, in order to embark on this path. With regard to pancreatic data, we don't expect anything else than what has been published released recently, and again, you know, mainly for prioritization, we believe that colorectal cancer phase IIb/III is the right way to go. This is where we have the highest chance of success vis-a-vis other indications such as pancreas and gastric. Right. Next slide, please. So to sum up this brief conference call, but still very important, because we've been able, for the first time, you know, in the history of Scandion to show that we have an MTD, therefore, we have a dose. So we remain one of the first movers in drug resistance. We are a resistance reversal company with this dual mechanism of action that was expressed in earlier conference calls, you know, targeting two biomarkers, basically. We are working in high unmet medical needs. Colorectal cancer at metastatic stage has a very poor survival rate of around 12%, and therefore we believe that we can help the patients. We can certainly provide an alternative to the current standard of care down the road. And clearly, we have been able to show, at least in open label data, phase one, phase two A, that we have an effective drug which has a broad commercial potential down the road, but also in some other indications as well. Johnny went through the cash management that we have been able to do up till now. We will continue to be extremely focused, and we will work with our newly appointed partner, Back Bay, which is, as I said, the Boston-based boutique firm, in order to find a strong partner with strong research in order to develop our compound and the combination with FOLFIRI forward. Having said that, you know, we obviously will be communicating at the right time, when we have some further data with regard to CORIST part three, the final cohort three, and also the last patient that we have enrolled into what we call CORIST Next Step, in order to show hopefully that we have good efficacy data. Right. Having said that, next slide, please. Yes. Having said that, I reemphasize the fact that we are in a good position. We are in the most favorable position in the history of Scandion. We have been able to demonstrate some efficacy data with our compound. We've been able to demonstrate a good safety, good tolerability, and we have been able to close the study on time, even ahead of schedule, actually, if I look at the CORIST next step, and now we are looking for the next step, potentially with a partner. Ready to take any questions you may have. If you wish to ask a question, please dial pound key five on your telephone keypad. The first question is from Christian Binder, from RedEye. Please go ahead. Your line is open. Hi, and thanks so much for taking my question. I just have one quick one regarding the increased partnering efforts. Can you just give any more color on you know, what kind of partnerships are you considering, and what kind of timeline should we look at in terms of when we will get news? Right. Thank you for your question, Christian. Well, obviously, I cannot disclose much about that, but certainly we are looking at big pharmaceutical companies, but also biotech companies such as small genetics companies, in order to provide us with the necessary muscles, financial muscles, to do a randomized clinical trial. All options are open, and we are certainly also will be looking potentially at financial alternatives such as fundraising, potentially as well. All right, got it. Thank you so much. That was all from my side. You're welcome. There are no more questions from the telco, so I hand the word back to you, François and Johnny, for closing remarks. Yes, so I just would like to thank you, our shareholders, that have been through some difficult times recently. We are very excited to move to the next step as a company, because we have been able to achieve this long first step, which is to basically enroll, get the data in, phase two A, and certainly very excited to move to the next step, and I hope you feel the same. Thank you again. This concludes today's call. You may disconnect your lines. Have a nice day.
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