Welcome to the Isofol Medical Q3 2022 Presentation. Afterwards, there'll be a question and answer session. If you wish to ask a question, please press zero one on your telephone keypad. Today, I'm pleased to present CEO Ulf Jungnelius and CFO Gustaf Albèrt. Please begin your meeting. Thank you so much, and welcome to our presentation of the third quarter results of this year. We are, as we told you before, closing down the AGENT study in accordance with ethical and regulatory requirements. If we go to the next slide, the disclaimer, please read it through while I go to slide number 4. Slide number 4 starts with Q3 highlights. Let's look at what's happened during the third quarter of this year. First of all, in early August, we presented the data from our randomized pivotal phase III study. Unfortunately and sadly, it showed that we did not achieve the primary endpoint of overall response rate or the key secondary endpoint of progression-free survival. Two endpoints there were required for a positive opinion by the FDA and EMA for marketing authorization. We have now worked during the third quarter, and additional study data during the quarter have confirmed the results of the primary and secondary endpoint, also on the survival endpoint. This led to the groundwork where we took the decision to stop the ongoing phase III study and terminate it early. Against this background, we have initiated a wind down of the study and termination, and we will continue doing that as fast as we can, and it will probably take us to the end of the year and eventually into the first quarter of next year. The final data, clinical data, and the gene expression data biomarker analysis are ongoing, and we will have a report hopefully during this quarter. Employees have been laid off, and we have terminated contractors. Keep in mind then that per law, you have a notice period in Sweden. Even if we gave them notice during the third quarter, termination will occur during the fourth quarter to start with. We are also looking into potential possible alternative for the company going forward. If you look on the financials, the results for the period amounted to SEK 32.5 million. Cash flow from the operating activities were SEK 44 million. We have a strong cash position at the end of the period of SEK 235 million, and we'll come in more into that a little bit later in the presentation. If we go to the next slide number 5, just a depiction of the phase III study to remind you, we enrolled 490 patients in the first-line treatment of metastatic colorectal cancer, with the control arm being modified FOLFOX6 with bevacizumab or Avastin. The only difference from the control arm was that we exchanged the leucovorin to arfolitixorin. We have the final data read out coming up during the fourth quarter. As I mentioned earlier, the primary endpoint was objective response rate, and key secondary endpoints included progression-free survival and duration of response. We had roughly 90 hospitals worldwide, and the coordinating principal investigators were Professor Josep Tabernero, in Spain and Professor Heinz-Josef Lenz in Los Angeles, USA. If you go to the next slide. The AGENT study did not meet the pre-specified primary or key secondary endpoints. The objective to get a positive opinion from regulatory agencies was that we should at least have a 10% improvement in response rate versus control. The secondary endpoint was progression-free survival, where the regulatory agencies wanted to see a non-significant but clinically meaningful prolongation. The threshold there was set to 1.8 months. The other thing was safety. We could not see a detriment in safety on overall survival. As a result, we did not see the difference in objective response rate. We did not meet at least 1.8 months of prolongation of progression-free survival. A little bit about the background to our decision to shut down the AGENT study. First of all, if we look on the objective response rate, and the P... The primary endpoint objective response rate, if you look at the P value, it was 0.85, and we need to achieve at least a 0.05. What this means is that 0.85 indicates that the response rates are very, very similar. On progression-free survival, we actually reached 12.8 months, which was something that we wanted to do. We also saw with a control arm that it reached 11.6 months. No difference that was required, keep in mind the 1.8 months. Our P value was 0.76. As if you remember, when we looked at the curves, they were superimposed. The more concerning thing, and that is mainly the biggest reason for us shutting down the ongoing study, was the analysis of overall survival. That was a key safety endpoint, and it showed a preliminary indication of a non-significant detrimental trend on the experimental arm compared to the control arm. What the FDA say, in no way can you have a detriment on overall survival compared to the standard of care. Unfortunately, this was what we identified. When we looked on safety, there were basically no differences on safety when we looked at the subgroups either through intention-to-treat or per-protocol. We could not identify any subgroup that stood out having a significant advantage for arfolitixorin. Based on this data then, it was not considered justified to continue the AGENT study. Keep in mind, with the detriment in overall survival, it was not ethical to continue exposing patients for arfolitixorin in the metastatic setting of colorectal cancer. We are still waiting for the gene expression analysis to come out. The basis then that we draw was that with the results we saw up to now and has been confirmed by what we've seen during the fourth quarter as well, is that there is no basis for submitting an NDA for approval. If we go to the next slide number 8. If we look on the process then of what we have been doing since August 4th. We are shutting down the study, and we began that immediately after we concluded that we had a detrimental effect on overall survival. For the patients, it means that the different hospitals are now switching patients over to their current standard of care, and continuing treatment. Even patients that had a positive response to arfolitixorin have been switched over. If you look on the clinics, the hospital, we are now harvesting documentation and doing quality control on their contributions. Once we have all data and also have destroyed the study medicine, we will close down the hospitals. This is a lengthy and bureaucratic procedure. That's why we can see that some of the hospitals may not be closed out during this year. If we look on the reporting, we are archiving all study materials in agreement with regulatory rules. We are drafting a final study report, and that is expected to be drafted during the fourth quarter of this year. Once we have the study report signed off, we will start working together with investigators on a scientific manuscript. That's the process going forward. That means that all contracts that we have are successfully being terminated. We think then that, as I said earlier, either by the end of the year or beginning of next year, we will be done with closing down the clinical departments on Isofol. If we look on the operations update, we have done significant cost cutting. If we look on the study, we are closing down sites, we are closing down contractors. The other thing was that once you realize that you have no basis for a submission, we also immediately closed down the pre-commercialization activities. We're also taking measures to decrease cost and also preserve the company's financial standing. We just noticed that we are a listed company on the Nasdaq, right? What we're waiting for now is basically the final manuscript on the clinical study. The other measures we have been taking is, as I mentioned, the pre-commercial activities all closed down, shutting down the AGENT study and compiling the final clinical study report, terminating contracts with subcontractors and vendors, and then we have started laying off employees. With that said, I will let Gustaf Albèrt, our Chief Financial Officer, take you on to slide number 10. Gustaf, over to you. Thank you, Ulf. Over to page number ten, financial review of Q3 2022. The revenues from reimbursement for the AGENT study from Japan continues into the third quarter and likely might continue into the fourth quarter. As Ulf mentioned, we have taken a lot of different measures to reduce and minimize costs. All pre-commercialization activities and costs have been stopped and closed in the third quarter. The AGENT study, all main costs for that, as Ulf mentioned, patients rolling over, et cetera, has been decreased and will, of course, continue to decrease going forward. As Ulf mentioned, relating to closing both vendors and terminating and giving notice to staff, there is a delay for reductions. Even though we can see a significant reduction or lower of costs and spending in this quarter, that will continue into the next quarter. Moving to the next slide 10, 11, sorry. As you can see, the cash flow from operating activities is less negative than previous periods, and that is, of course, related to the lower results for the period and also corresponding to the activities that we have taken in order to decrease both costs and improve cash flow, minimize the cash flow. Cash position at the period end is SEK 235, and the working capital is SEK 184. Over to you again, page 12. Okay. Thank you. Thank you. Let's see. Here we go. This is the last slide then, just sort of a recap on what has been said here. What we're doing now going forward is we're focusing on a diligent, efficient, and high-quality approach of analyzing and collecting the final data. That includes, of course, subgroups, the gene expression data. Hopefully, we'll be able to start writing up the manuscript during the fourth quarter and publish it. We are shutting down the study in accordance with all the regulatory requirements and ethical considerations. Again, I'm hoping that the study will be shut down by the end of the year or beginning of next year. As Gustaf said, we are implementing significant measures to decrease costs and safeguard the company's financial position. The other thing we're doing now is to evaluate and investigate alternative operational courses of action, including collaborations or structured deals to ensure the greatest value for Isofol and Isofol's shareholders. Once again, I'd like to thank all the shareholders that have been supporting us for this. The unfortunate results was not expected, of course, but this is biotech, this is drug development. It is a high-risk enterprise where the rewards are very high, but eventually you also end up in, as we have done, in negative results. Then you have to basically maneuver so that you keep as much of the shareholder value as possible. With the cash position we are in, we are noticing that we are highly attractive for companies today. Hopefully, we will find a way forward for Isofol that will benefit our shareholders. With that said, I leave the word to our facilitator. Over to you. Thank you. If you wish to ask a question, please press zero and one on your telephone keypad. Our first question comes from Christian Binder at Redeye. Your line is open. Hi, and thank you so much for taking my question. Just a quick one. I wondered whether you could elaborate a little bit more on different alternatives after winding down the AGENT. I mean, you already talked about, you know, potential structural deals or collaborations, but could you elaborate a little bit more on, you know, I guess the two alternatives is either you liquidate or you try to do some deal and in that way go forward. Can you just elaborate a little bit more on your reasoning, what different factors do you consider when you think about maximizing shareholder value? Yeah, I can do that. First of all, if we look on our pipeline in oncology with the clinical results, specifically the overall survival results, this drug is tainted in oncology. Finding other routes in the area where we have freedom to operate according to our contract with Merck is basically closed down. What alternatives do we have compared to a controlled liquidation? A number of companies are desperately trying to raise money in the circumstances that we are in today with the financial crisis, the inflation, and the interest rates going up. Of course, our shareholders invested in healthcare. We are looking for companies specifically and most desirably in the healthcare sector. Companies that our shareholders would probably say are not super high risk, but they come a bit further ahead in what they've been trying to do. Basically, that's the type of companies we're looking at, and seeing if a deal or something can be struck with a company where we would be able to use our shareholders' value to maximize the shareholder price, either being incorporated into another company or merging or acquiring. The door is open. We haven't set any stakes in the ground saying this is the way forward. We are listening and actually seeing a number of fantastic opportunities being presented for us. It will be up to the board to decide the way forward. We're also feeling that should something happen, it should basically be a decision that happens fairly fast so that we can use the cash position we have to boost the shareholder value. I don't know if that answers your question. No, that definitely answers my question. Just quick follow-up there. I guess we can expect a more clear communication on which path you choose forward in Q1 next year. Do you have a timeline or is it uncertain right now? That would be my hope that by the Q1 report, you will have the results of our efforts in clear text. Got it. That was all from my side. Thank you so much. Thank you. As a reminder, to ask a question, please press zero one on your telephone keypad. We will have a brief pause while any questions are added to the queue. We have no further questions on the phone line, so I'll hand back to the speakers. Thank you. There is a couple of questions on the web. The first one is at the end of September, there were 15 full-time employees and about 10 consultants. With the termination of employee contracts, how many employees do you expect to have at the year-end of 2022? Difficult question. Depends on where we are with the closing down. We can't terminate all staff and have work left, right? We have to be diligent. I would expect that if we haven't reduced the workforce by more than 50%, we haven't been diligent. Thank you. Could you elaborate a bit on the average termination period for the employees being laid off? That's hard because, according to Swedish law, depending on how long people have worked in the company, the notice period seems to increase with the years worked. Baseline is usually, I think, around three months. If you give notice in the third quarter or end of third quarter, you'll see people leaving by the end of the year or in December. We already have people that have left the company, so the process is ongoing. Thank you. Finally, what is your estimate on the year-end cash balance? I think that's the question that my dear financial, Chief Financial Officer should speculate around. Gustaf. Okay, thank you. In addition to what you said in the previous question, then, of course, the 10 consultants that was mentioned in the Q2 report will be significantly reduced in Q4. The cash balance at year-end, we have to come back to that because that all, of course, depends on the successful implementation of the different activities. We see that we are making progress, and we are making good results with the activities and measures we are doing. It will be, of course, less than what we have now. If you look into the Q3 report, you can see that the burn rate has been reduced significantly and that will continue to be reduced significantly. We do not really want to get a number for the year-end, but it will be a reasonable good number. Thank you. By that, I'll hand back to you, Ulf, for your concluding remarks. Okay, thank you. Okay, thank you so much for listening in to this Q3 report. As we indicated when we talked the last time, we have done significant cost reductions. We are still working diligently on understanding the data. By the fourth quarter, my hope is that we will have a full report signed and that hopefully we will also know the way forward for Isofol. With that, thank you so much for listening in, and we'll be back. Take care. Thank you.