Welcome to the Scandion Oncology Q3 2022 report. Throughout the call, all participants will be in listen-only mode, and afterwards there will be a question and answer session. Today, I'm pleased to present Acting CEO and CFO, Johnny Stilou, and CMO, Alfredo Zurlo. Please begin your meeting. Thank you all, and good morning, everyone, and welcome to our third quarter 2022 interim report investor call. As you just heard, my name is Johnny Stilou. I'm the Acting CEO and CFO of Scandion Oncology. With me today is our Chief Medical Officer, Alfredo Zurlo. Alfredo and I will be updating you on the development and financial results for the third quarter of 2022, as well as recent events. We had a busy third quarter as we continued to execute on our strategy and advance our clinical trials. Further, we have taken steps to enhance our financial position, reducing costs and prolonging our cash runway. Following our presentation, Alfredo and I are happy to take your 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, so if you have a question, please follow the operator's instructions and ask verbally. Please note that you will have to dial into the call to be able to state a question. This cannot be done through the webcast. Again, welcome and thank you for your interest in Scandion. Next slide, please. Before we begin, let me just remind you that we'll be making forward-looking statements during this call and that those are by nature subject to significant risks and uncertainties, as described in our disclaimer here. Moving on to slide three for the agenda. In our call, I will firstly update you on the development in the third quarter of 2022. Alfredo will provide an update on the CORIST trial and an overview of our pipeline of clinical and pre-clinical programs, after which I will present our financials. Lastly, we will talk about expected upcoming milestone events and our external profiling activities, ending with a reminder of our core strengths as a company. Next slide, please. At Scandion, we discover and develop first-in-class medicines aimed at treating cancer, which is resistant to current treatment options. We are among the world's leaders in reverting the cancer's resistance against treatment, thus making the treatment work better and longer, thereby potentially prolonging and improving the life of patients who would otherwise have a high risk of dying from their cancer. This will, of course, also improve the life of patients' relatives. Globally, close to 10 million patients die every year from treatment-resistant cancers. To us, that is simply unacceptable, and help bringing this number down is what motivates us going to work every day. We have both the expertise and the molecules to help solve this massive problem in cancer treatment. Our medicines are relevant in several different cancers. This gives us the potential to provide treatment to millions of people who today don't have effective treatment options. That makes both our medical and commercial potential significant. Please turn to slide five. We had a busy third quarter as we continued to execute on our strategy and advance the CORIST and PANTAX clinical trials with our lead compound, SCO-101. We are happy to have extended PANTAX, and we're also pleased to have progressed CORIST with the initiation of part three of the trial. Momentum in both trials remains solid as we maintain our strong operational execution and timelines. Based on our learnings from the trial so far, CORIST parts three and four are designed to provide the optimal way to dose SCO-101 to ensure maximum effect in patients with metastatic colorectal cancer. We know more about the drug today than when designing part two and are optimistic that the CORIST trial will, when ultimately completed, provide proof of concept for SCO-101 in this indication and combination. Alfredo will provide more details in a minute. Most importantly, we initiated part three of the CORIST trial with the first of up to 36 patients enrolled in early October and have already recruited three patients by today. Our financial position remains strong with our current cash funding the company into 2024. We work to extend this funding even longer into 2024 through strict cost control and cost reductions where possible. To this end, we have, by the end of October, reduced our staff with four employees, bringing the total organization down to 10 employees. While we regret to have let these competent people go, this will, however, prolong our funding runway while we maintain our overall strategy and an experienced organization capable of executing on our plans. As per our strategy and business model, we will need to secure additional funding sometime during 2023. To this end, we obtained authorizations to carry through issues of shares at an extraordinary general meeting held in October. This enables us to engage in discussions with potential institutional investors and partners to possibly attract additional funding when needed and opportunities arises. Please turn to the next slide for more details on our financial position. As many of you will know, we enhanced our cash position during the summer, raising approximately SEK 75 million in gross proceeds through a right issue. This extended our funding into 2024, allowing us to continue to execute on our plans and progress our trials. Considering the current macroeconomic climate and the state of the financial markets, we are extremely pleased to have secured such a relatively long funding runway. Still, we don't just sit back but work actively to further extend the runway. This is why we, in October, as mentioned, reduced the number of employees to 10. While we do regret to have let these people go, this will lower our monthly spend and thereby prolong our funding runway while we maintain our overall strategy and an experienced yet lean organization. We also maintain strict cost control throughout the organization. With cash on hand to fund us into 2024, we will need to find additional funding sometime during 2023. As always, we will consider different sources of capital and want to have as many opportunities as possible. Having obtained the authorizations to issue shares, both with and without preemptive rights for existing shareholders at the extraordinary general meeting, we are now able to initiate such issues if and when opportunities arises. As also communicated in October, we have no immediate plans to issue shares and will not need new funding anytime soon. Now we have the prerequisite in place to pursue the best future funding opportunities so we can continue to invest to create long-term value for Scandion, our owners, and the patients. I will now hand over to Alfredo to give an update on CORIST. Next slide, please. Thank you, Johnny. As you know, the current focus of Scandion Oncology clinical development is in metastatic colorectal cancer because of SCO-101's unique dual mechanism of action when combined with FOLFIRI chemotherapy, an active and commonly used chemotherapeutic regimen for this indication. Irinotecan, the main active agent of the combination, shortly after administration, is transformed in the blood into SN-38, the active metabolite. SN-38 in the blood is then promptly inactivated by the enzyme UGT1A1. The amount of SN-38 that manages to enter the cells is inactivated in different ways, including active excretion by the drug efflux pump ABCG2. Once SN-38 is expelled back into the blood, it will be inactivated, as already seen, by UGT1A1. As you can see next slide, SCO-101 has a dual mechanism of action potentiating SN-38 cytotoxic effects. The first one is the inhibition of UGT1A1, increasing the plasma concentration of SN-38 while avoiding the degradation of SN-38 into inactive compounds. Next slide, please. The second is blocking the drug efflux pump ABCG2, thus allowing increased amounts of SN-38 to remain longer into the cells. Moving now to next slide. The CORIST study explored the safety and efficacy of combining SCO-101 and FOLFIRI in refractory metastatic colorectal cancer patients. It consists of four parts, as shown here. Top line results from part one and part two have been communicated, and part two is still ongoing. Independently of part two, part three was initiated in October with three patients now recruited in the first cohort. Following completion of part three, we plan to initiate part four. Part three and four will enroll patients with both RAS wild type and RAS-mutated metastatic colorectal cancer. Part three will evaluate the safety and tolerability of SCO-101 in combination with FOLFIRI when dosed according to a different schedule than the one used in part one and two, as we can see in next slide. In CORIST part three, SCO-101 will still be administered over six days in a biweekly cycle. Similarly to part one and two of the study. The main difference with this new schedule is that FOLFIRI will be administered starting on day two-four. This is done to modulate the effect on the two targets that we know are hit by SCO-101. UGT1A1, which is relevant until irinotecan administration has been completed and all the drug is transformed into the active metabolite SN-38 in the blood. ABCG2, which is relevant after SN-38 has entered the cells to prevent that this is excreted too quickly. The overall approach aims to control the initial peak of SN-38 in order to improve safety and tolerability and to prolong the permanence of the active metabolite into the cancer cells in order to improve efficacy. CORIST part three is planned to include up to 36 metastatic colorectal cancer patients with RAS wild type and RAS-mutated tumors in up to six dose escalation cohorts with a standard 3+3 design. In CORIST part four, up to 24 metastatic colorectal cancer patients will be enrolled to assess the preliminary activity of SCO-101 combined with FOLFIRI when administered at the optimal dose found in part three. Next slide, please. Top-line results from CORIST part three are expected most likely within the third quarter of 2023. As the number of recruited patients may vary greatly depending on the toxicity we will observe, we plan to give an update on the expected timeline of Part three completion before the end of Q1 2023. Whenever recruitment of CORIST Part three is completed, we will inform about the dose reached and the safety and tolerability that we have observed with the new schedule. We will inform about the preliminary activity observed in Part three patients too, even though this will be necessarily incomplete, as some patients will still be receiving treatment at this stage. At this time point, we will also give a final update about Part two, with the focus on updating the outcome of those patients who are continuing treatment as of today. Top line results of part four will be communicated after all patients have undergone at least the first CT scan on study at eight weeks. Similarly to the top line results provided recently for part two, this will be an early and necessarily incomplete picture, as several patients will be likely still receiving treatment at this early time point. This is expected either in the second half of 2023 or first half of 2024, depending on the overall number of patients that will be recruited in the study. The final comprehensive CORIST study results can be expected approximately six months later. Moving to slide 13. This slide gives an overview of our pipeline. Illustrating the SCO-101 is our lead asset with potential 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. With that, I will hand back to Johnny. Thank you, Alfredo. Please turn to slide 15. In this slide, you can see our financial results for the third quarter and the first nine months of 2022. It is a pleasure to once again state that results are in line with plans. We follow our investment plans and are in good control of our cost. Increase in research and development reflects the development of our two ongoing clinical trials. Please note that severance to the former CEO and COO have been accrued in total in the quarter. Due to the mentioned layoffs and overall cost control, both research and development and general admin costs will begin to decline in the coming periods. Note that fluctuations between quarters may occur. Moving to slide 16. As you can see on this slide, our cash spend in the third quarter was on the same level as the second quarter, reflecting primarily the continued momentum in the clinical trial. We do not expect to maintain spend at this level going forward. As mentioned before, our current cash position funds our operations into 2024. This implies that additional funding is needed sometime during 2023. Next slide, please. We are looking forward to 12-15 exciting months for Scandion with more significant events expected. Our top priority is the execution of CORIST part three, for which we currently expect top-line data in the third quarter of 2023. Based on this data, we will make decisions how to conduct the fourth and final part of CORIST. Top line data from PANTAX is expected in the first half of 2023, following the extension of the study based on the continued dose escalation. The data will support the overall profile of SCO-101. Let me just remind you that the execution of PANTAX and CORIST Part three are covered by our current cash position to take us into 2024. Next slide, please. We continue to prioritize the profiling of Scandion through proactive communication with external stakeholders. Our journey towards delivering new treatment options for cancer patients requires long-term focus and insights, and there will be many value inflection points along the way. It is important for us to communicate so that these points will be visible to all stakeholders. To this end, we have been actively participating on a number of conferences, and we will continue to be going forward. We are looking forward to again present at conferences in the coming months, and, as outlined here on the slide, are always open to opportunities to present Scandion to relevant audiences. Please turn to slide 19. To sum up, we had a busy and productive third quarter and remain focused on our priorities, first and foremost, the CORIST trial. We will continue to leverage our strength as first movers in cancer drug resistance with both a significant medical and commercial potential. With that, I conclude our presentation, 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. If you have a question for the speakers, please press zero one on your telephone keypad. Our first question comes from the line of Christian Binder of Redeye. Please go ahead. Hi, thank you so much for taking my questions. To start with, you know, as you said it in the quarterly report, you have reduced staff somewhat during the quarter. Looking forward, Johnny, and now you're Acting CEO and CFO, given the cost-cutting measures, are you going to look to recruit a new CEO, or are you planning to continue in the current constellation when it comes to executive management? Thank you, Christian. The process of finding a permanent CEO is actively ongoing, and a recruiter has been engaged to find a new CEO. As I'm sure you are aware, the process of finding a CEO is something that takes time. I cannot give any specific timelines, but of course, once a conclusion has been reached, we will of course inform the market. Got it. A second one. Your focus seems to be clearly on SCO-101 development in colorectal, but can you talk a little bit more about SCO-101 in pancreatic cancer? I mean, considering both potential needed investments but also the drug candidate's potential in indication. How are you looking to progress in that indication after concluding PANTAX phase Ib? As we have stated, there's no doubt currently that our main focus and priority is the CORIST trial. The PANTAX study is ongoing to find the optimal dose there, and expected in the first half of 2023. Once we reach that point, we will then evaluate the best way to push PANTAX forward. Again, to state, there is no doubt that currently our main focus is the CORIST trial. Understood. That was all from my side. Thank you. Just to remind everyone, if you would like to ask a question, please press zero one on your telephone keypads. There are no further questions on the telephones at this time. Please go ahead, speakers. Thank you very much. Thank you all for listening in to our third quarter call. Have a lovely day all. Thank you. This now concludes our conference call. Thank you all for attending. You may now disconnect your lines.
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