Ladies and gentlemen, welcome to Scandion Oncology CORIST part 2: Top Line Data Conference Call. For the first part of this call, all participants will be in a listen-only mode. Afterwards, there'll be a question and answer session. To ask a question during the Q&A, please press five star on your telephone keypad. This call is being recorded. I'll now hand the call over to the speakers. Please begin. Thank you, and good morning, everyone, and welcome to this investor call during which we will talk about the top line results from the second part of the ongoing CORIST trial. My name is Johnny Stilou, and I am Acting CEO & CFO of Scandion Oncology. With me today is our Chief Medical Officer, Alfredo Zurlo. We will be updating you on the top line results. Afterwards, we encourage you all to ask questions. Please be informed that in order to best address your questions, we ask you to state these verbally. It will not be possible to put questions forward in writing. If you have a question, please follow the operator's instructions and ask verbally. Questions and comments we have received prior to this call, we will try to address during our presentation. Again, welcome and thank you for your interest in Scandion. Next slide, please. Before we begin, let me just remind you that we will be making forward-looking statements during this call and that those are by nature subject to significant risk and uncertainties as described in our disclaimer here. Moving on to slide 3. I would like to begin with a reminder of the enormous burden put on patients, relatives, and society by cancer. This is clearly described by the staggering number on this slide. 10 million people lose their life to cancer every year, most of these because the cancer is resistant to treatment. Helping ease this burden and bring down the number is essentially what we at Scandion are trying to do by developing medicines that can treat cancers which are resistant to current treatments. We are currently addressing some of the deadliest cancers, colorectal and pancreatic cancer, with our clinical trials, CORIST and PANTAX, investigating our lead compound, SCO-101. If we are successful, we may provide first-in-class treatments as there is currently no treatments today that can do what we aim to do. Obviously, this is not a simple task, but the benefits could be massive, and we believe we have both the expertise and the molecules to be successful. Next slide, please. This slide provides an overview of our pipeline, illustrating that SCO-101 is our lead asset with potential in multiple cancers and also in combination with immune therapies, which we are studying on a preclinical level. We are also conducting preclinical activities with our second molecule, SCO-201, in solid tumors. In our call today, we will of course focus on the second part of CORIST and the top line results from this. Let me note that the trial will continue. Part 2 will go on for as long as patients are on treatment. Independently hereof, we expect to initiate part 3 shortly. I will now hand over to Alfredo, who will speak more about the results and the different part of the CORIST trial. Please turn to slide 6. Alfredo, please go ahead. Thank you, Johnny. I will start presenting the CORIST study design and endpoints. CORIST is a phase II study with primary endpoint overall response rate according to RECIST 1.1. As original design, it also contains a dose escalation part, which we call part 1, to identify the most suitable dose of the SCO-101 in combination with the FOLFIRI chemotherapy in a schedule over 7 days in metastatic colorectal cancer patients. After a suitable dose has been found, an expansion of 25 patients, part 2 that we are discussing now, would assess the efficacy. Based on part 1 and part 2 pharmacokinetics and pharmacodynamics evidence that we had around this summer, the study is being recently amended to explore the potential of a different schedule over 6 days, expected to be possibly the best way to combine SCO-101 and FOLFIRI chemotherapy. These are the part 3 and 4. The new part 3 will try to escalate the dose of SCO-101 and FOLFIRI above dose employed in part 2. Once this dose has been identified in part 3, part 4 will confirm in up to 24 patients the efficacy of this combination, again, based on overall response rate. Also, there will be other usual secondary endpoints such as progression-free survival and overall survival that will be assessed. You can see as originally designed, we had only part 2. Now we have also another expansion, part 4. The study design has been somehow changed to find the best schedule between these two. Next slide, please. We are now talking about the top line results of our CORIST part 2 that we have as of today. The dose identified in part 1 as planned was exploring 25 RAS wild type patients, all of whom had at least a CT scan after eight weeks of treatment as per protocol. The feasibility and safety of combining SCO-101 and FOLFIRI in a schedule over 7 days was confirmed. Part 1 in this respect, part 2 confirms the finding of part 1. Tumor reduction has been observed in some patients. However, this was below the 3% at least threshold defined as the primary endpoint of the study. This is according to RECIST, the method we use to evaluate this overall response rate. Thus, a proof of concept for efficacy was not reached, as no RECIST response of at least 30% were observed at this primary time point of 8 weeks from treatment start. Evidence of prolonged progression-free survival with stable disease, which are secondary endpoint, were observed in some patients. Overall, the evidence gathered so far from part 2 of the study, including safety, preliminary activity, and pharmacokinetics, support the expansion of the study to investigate the potential improved modality for combining SCO-101 and FOLFIRI chemotherapy. Next slide. Let's talk about the expansion of CORIST, the part 3 and 4. The CORIST trial is now being expanded by adding a new schedule for combining SCO-101 and chemotherapy over six days, sorry. Which will be evaluated in patients with both RAS wild type and RAS mutated metastatic colorectal cancer. CORIST part 3 will evaluate the safety and tolerability of SCO-101 in combination with FOLFIRI when dosed according to this different schedule. CORIST part 3 is planned to include up to 36 patients, both with RAS wild type and RAS mutated tumors. Basically, this number 36 comes from six escalation levels cohorts, and each of them can have up to six patients. It is called a 3+3 design. If you don't see any major toxicity, you stop after three patients. If you see instead one event, you have to expand the cohort. If you see in any cohort two toxicities, you have to go down one step. It's difficult to speculate if we are going to recruit to 10, 20, 30, 36 patients as we are starting now. Top line results from CORIST part 3 are expected most likely within Q3 2023, and that's because of this uncertainty. We guess that we should be there in Q3 2023. In CORIST part 4, up to 24 metastatic colorectal cancer patients, again, RAS wild type or mutated, will be enrolled to assess the preliminary activity of SCO-101 combined with FOLFIRI, administered at the best dose, at the right dose that we identified in part 3. Next slide. Let's see when we are planning to communicate further about the evolution of the study. In Q1 2023, we will update you on the expected timelines of part 3 completion. If we are confident that the Q3 timelines that we are giving now can be met, and that we will know by knowing how this escalation is going. If seen in the first course, how much toxicity and how much patient we had to use. If the course were expanded to six or to only three patients was enough. When CORIST part 3 is completed, we will inform about the dose reached with top-line results about the safety and tolerability of this new schedule, and also we will inform if we saw any activity, which kind of activity we've seen in past patients. Obviously, since it's just completed, not all patients have been valuable for activity, but many of them would. At this time point, we will also wrap up a bit the part 2 patients. We'll give an update and, especially focusing on those that are still on treatment today. Top-line results of part 4 will be communicated after all patients have undergone at least the first CT scan on study at 8 weeks. The part 4 top-line results update will be very similar to the present communication that we are giving about part 2. We expect this to occur sometime in second half of 2023 or first half of 2024. We cannot be more precise now because this will depend on the number of patients recruited in part 3. 15, 30, we don't know yet. The final CORIST study results can be expected approximately 6 months later because these top-line results are based on the 1 CT scan at 8 weeks. The final study results will be comprehensive with all the available information on long-term efficacy also. With that, next slide, and I pass back to Johnny. Thank you, Alfredo. With that, I conclude our presentation on the results and thank you for your attention. We are now ready to take your questions. Again, please remember that you can only state your questions verbally. Back to the operator. Thank you. To ask a question during the Q&A, please press five star on your telephone keypad. To withdraw your question, please press five star again. We'll have a brief pause while questions are being registered. Can you increase a bit the volume? Our first question is from Harry Shrives from Edison Investment Research. Your line will now be unmuted. Hi, Johnny Stilou and Alfredo Zurlo. Thanks for taking my question. So I wanted to ask first off if you could comment on any potential read across you see between the results in CORIST part 2 and the upcoming readouts from the PANTAX Phase I-B study, specifically in terms of efficacy. I know there's some survival secondaries or for the PANTAX study. Yeah, if you could comment on that would be appreciated. Well, thanks for the question. This call is not really about PANTAX. We informed that we have reached a higher dose with it than expected at certain point in PANTAX, but we are not ready to give any updated activity to even the preliminary results that we have on PANTAX. We are discussing here only the outcome of CORIST. I don't know if my slides presentation has provided additional information you were seeking to obtain, or if not, based on CORIST reading, please formulate a different question. Okay. Thank you. Moving on from that then. As you've mentioned, the longer-term data from CORIST part 2 is gonna be sort of important moving forward. Could you give us an idea of when we can expect that to be reported? Is this a 6-month, a full 6 months from full enrollment as well, as you mentioned in the part 4? Yeah. Since the study is still ongoing, we have seven patients who are still receiving treatment. We can give an update by the time we will inform about the dose we have found to completing part 3. I think that's, you know, the right moment to inform because that's the moment when we have to make a confirmation saying part 3 has been completed, these are the doses we bring forward in part 4. By that time, since we expect this to happen within 6, 9, maximum 12 months, depending of the size of part 3, that will be certainly a good moment to wrap up the data of part 2. Obviously, since the study has changed and then, the overall evaluation will be done after also part 4 results are available, that will be only, let's say 50% of the outcome, and the other outcome will be instead also the efficacy found in part 4. Okay. Thank you. Finally, I was just wondering, can we expect some more detailed results to be published from CORIST part 2 when we receive the full long-term data, or will there be a more recent, sort of a more near-term announcement on that? Well, with the amendment, the statistical section has been modified. We are now really using CORIST to compare two schedules of combining SCO-101 and FOLFIRI chemotherapy, one over 7 days, where we give 5 days of SCO-101 before starting FOLFIRI, and the other one over 6 days, where instead of FOLFIRI started earlier. This because we believe this could be the best way to modulate the peak of SN-38 that we see. In reality, we are planning to bring a final outcome saying we have these two ways of combination, and we would say that the best way to move forward is part 2 or part 4 scheduling. I'm thinking to bring the data into this context rather than presenting a partial results that per se are not necessarily meaningful. Taking my question. Thank you very. Thank you. As a reminder, to ask a question, please press five star on your telephone keypad. We'll have a brief pause while further questions are being registered. It was five star to ask a question. As there are no further questions, I'll hand it back to the speakers for any closing remarks. Thank you. Thank you all for your attendance today. Hand over back to the operator to conclude the call. Thank you. This now concludes the conference call. You may now disconnect your lines.