Good morning, everybody. Thank you for attending this webcast. Is with the great pleasure that we, you know, we look forward to present to you the preliminary results from the NIPU study. Before that, I want to take the opportunity to give a big thank you to all the patients, investigators, and their families for participating and for their commitment in really helping the medical community to becoming more knowledgeable about a very, very difficult type of cancer to treat. Of course, a very special thank you to Professor Åslaug Helland and her team for, first, for their interest in, really using UV1 in her patients, and for the dedication to follow these patients for this, extended period of time, and also now for all her enthusiasm in, presenting the data at a future conference. You know, we will, touch basically, briefly, initially, just a little bit on the study so that everybody understands and the preliminary results. Then I will talk about how the impact of these studies are in the ongoing clinical program, that we have quite a broad program, in the other studies. With this, I will give the word to Jens, and of course, I need to show you the next slide, the disclaimer, and then I give the word to Jens, and I will come back at the end. Thank you, Carlos, and good morning. There's a few slides here on the NIPU study, though. First, I would like to say a few words about investigator-initiated studies. NIPU is an investigator-initiated study. This means that investigator, in this circumstance, Oslo University Hospital and Åslaug Helland's group, owns the data and decide when to disclose what. In this study, Ultimovacs has been invited, so we collaborate in this study, and we provide drug to this study. The data from the study will be presented at the medical conference, no further data will be disclosed at this point. It's very important then with the investigator-initiated study, that we fully respect and understand that this is data and a study owned by a different party. This is also important in the work moving forward in different indications. Over to the next slide, just to give a background on the study as such. The NIPU study is a randomized study in malignant pleural mesothelioma. It's a randomized study, randomization one to one, and totally 118 patients were included in this study. First patient were included in June 2020, and the last patient were included in January this year. In the two arms in this study, all patients are receiving ipilimumab and nivolumab for up to two years treatment, and in the experimental arm, the patients also receive eight doses of the vaccine UV1. The readout of this study is PFS, and this is something that was decided prior to study start to occur when 69 PFS events were reached in the study. On the next slide, you can see the slides, the results that are available at this point. As informed in the press release, the NIPU phase II trial did not meet its primary endpoint of progression-free survival based on blinded, independent central review. This means the blinded, independent, central review, the slides are sent to a third-party vendor and analyzed and assessed by radiologists working there. As part of a primary endpoint, there are also different sensitivity analysis that are bound to the primary endpoint. You test the slides and the review of slides with different methodologies. One of these are to also assess the images with local assessment. This means that the radiologist at the hospitals are reviewing the pictures. This is a part of the predefined analysis of the primary endpoint. This one showed a statistical significance improvement in PFS for patients receiving UV1. The current data in this study indicate improvement in overall survival in the UV1 arm over the control arm. The data need to mature before a conclusion can be reached. For the safety in this trial, it was similar in this study in both arms. This is confirming good safety profile for the UV1 moving forward with development of the vaccine. Moving on to the next slide, I give the word back to Carlos. Thank you, Jens. As Jens mentioned, you know, this is out of our five phase II studies ongoing, NIPU is the first one to deliver data. You know, we know that this was gonna be a challenge. Mesothelioma is a very difficult cancer to treat. These patients are second-line treatment patients, you know, when basically there's no standard care, many other alternatives. You know, we believe the data is encouraging, and I will touch a little bit based on that. The fact is that NIPU is just one out of these five studies that we have ongoing. As you know, our lead indication is melanoma, and we have the INITIUM study running. You also know that we communicated that we needed to change the guidance in terms of disclosing the data because patients are taking longer to progress or die, and the 70 events that determine when we stop that study to analyze the data is taking longer. Of course, then we have other studies running. Important here to highlight that, in addition to NIPU, FOCUS, DOVACC and LUNGVAC are all investigating initiative studies, and this shows the big interest from the medical community and pharma companies to use UV1 and test UV1 in different indications and in different combinations. You know, if we move to the next slide, you know, I just want to make sure that we have some key takeaways from this data. This is an investigative study, as Jens mentioned. The principal investigator, the group owns the data, and they decide what to disclose and when. As you can imagine, it's of great interest, and they believe that they have strong data in this study so far, and they have a target to present this at a major medical conference. We need to respect that they want to make sure that they will have as impactful data as much as possible when they disclose that. Mesothelioma is a very hard to treat form of cancer, particularly in second-line treatment. As I mentioned, there's no established standard of care. You probably know if we look even in primary first line, keeping even in ipilimumab and nivolumab, that is a combination that we use in our NIPU study. When they had the data from the phase III study, there was no difference in PFS or progression-free survival between the IPI-NIVO versus chemotherapy. They had a difference in overall survival, and that is a very important efficacy measure for the authorities. That's the main endpoint that they concentrate in terms of asking the companies to deliver on overall survival. Even recently, just beginning of this week, MSD showed the data of pembrolizumab plus chemo versus chemo, and there was no difference in terms of PFS between the two groups. Clearly, PFS is not the right endpoint, but, you know, this is at the moment, that's what we have. It's important, as we found in the study so far, that overall survival, that is really the gold standard and what everybody is looking for. We had quite a positive impact on survival, you know, in the study so far. This data needs to mature, and this means that, you know, the last patient was enrolled in January, so there are still several patients that need to cross the 12 months, so that the full survival, overall survival is evaluated. So far, this data looks quite positive. You know, when we put it all together, how hard it is to treat this type of cancer, how no differences in PFS in several major clinical trials are the norm. You know, we are not overly surprised that there was no difference in PFS in the study. We were pleasantly surprised with how significant the study is when we look at the images reviewed by the local radiologist. If the study would have been the primary endpoint, would have been measured by the local reviewers, this would have been a very positive study with very significant statistical statistics, and that in really encourages. You know, the fact that we have, you know, quite supporting phase I data, the fact that we see also in INITIUM, that the patients are responding better to treatment with delayed progression and death. The data that we both of us and BMS received from the investigators, really increase our optimism in terms of the value of UV1 and the impact that may have in treating cancer patients in the other ongoing trials. I know there is a little bit of disappointment regarding the primary endpoint, but the study is a phase II study, so it's a study that will give us very important information on how to move forward with the development of UV1 in mesothelioma. As you know, when we move to a regulatory study, a phase III study, the primary endpoint is overall survival. In that regards, we so far have very positive indications that there is an impact of adding UV1 to IPI-NIVO versus IPI-NIVO alone. Overall, from the perspective of the investigators, from the perspective of us in the company and from our medical team, we find this data being quite supportive of UV1. Of course, we look forward to when the investigative team presents the data at a medical conference to get the full details in terms of the HRpfs, in terms of survival, in, you know, full details on the, on the safety and other, and other endpoints that the study will analyze. I can tell you that from our perspective, we feel very confident on this data, and we are increasingly optimistic about the real impact of UV1 on treating these patients when we combine with these different classes of drugs. With this, I want to thank you for your attention, and now we can open the floor to Q&A. We have received several questions. Several questions address the same topics, so we will then try to pull some of these questions together to avoid asking all of them, of course, that cover the same subject. We can start with the following: Regarding the supportive analysis performed by the radiologists at the different sites, was the analysis performed in a blinded manner? This study is not a blinded study as such. You can say that the central review will be a blinded review of the images. It's a third-party vendor that is looking at the pictures and assessing them. When it comes to local assessment of the pictures, there is no information as such going from the investigators to the radiologist at the different hospitals. Also there is a risk that there is information there that could give information so that they know what kind of treatment the patients received. It's a possibility for such information. Remember that in this study, both arms, both the ipilimumab arm and the nivolumab ipilimumab arm are experimental treatment. ipilimumab was not and is not approved as second-line treatment for these patients. It's investigational for both arms. I also would like to repeat that, this analysis, this local assessment of the pictures is a part of the primary endpoint. It's a sensitivity analysis of the primary endpoint, and this is something that is predefined in the protocol. Thank you, Jens. Next, question: Is it so that some studies use local assessment instead of central review to determine if the primary endpoints have been reached? If Retrophin had done that in the NIPU study, would the NIPU study then have met the primary endpoint? Yes. This is always a difficult decision to take. As I just said, there is more confidence from the authorities in a central review, so that is something that is expected in a phase III, for example, if you want registration of the drug. In this trial, it is also central review, as mesothelioma is a hard-to-treat indication with few options for the patients. It would be beneficial to have central review upon readout of a positive results. On the other side, there is a lot of trials that use local assessment, not at least in phase II trials, where you want to get information, as Carlos said, for further development in phase III. For both the central review, and this sensitivity analysis, it's the same statistics, as we have disclosed earlier, with a hazard ratio of 0.6, one-sided alpha of 0.1, and a power of 80. If the local assessment had been, the primary endpoint in this study, the study would have been a positive trial. That's correct. Okay. Thanks, Jens. The next question on HR values: Have you got the HR values? In case you have, why not let the market know the values? It's a very good question, and this was, you know, a dialogue with the investigator team. Basically, the outcomes of that discussion was as this team believes that they have very strong data to present a medical conference, their preference was to disclose these HR values at that conference. What we can tell you, as we put in a press release, and as Jens just mentioned, if the HR values in the local review would have been a very positive study with very strong statistics, under central review, we didn't meet the primary endpoint. This is, as we mentioned, this is the preference of the lead investigator, and they own the data. Of course, they want to make sure, because they believe that they have very strong data to get a very good presentation at the medical conference. Thanks. next question: Despite not seeing a positive outcome in the primary endpoint of the trial, do you see a positive trend close to significance? You know, again, we cannot comment on that because that would be through the lies. That was the decision from the investigator to save those details to the conference. You know, I just said, you know, basically what was the results if you look at the strength of the data, if you look from a central review or from a local review. Thanks. Next question: What was the cleaning time for the NIPU data? you know, that's again, that's a process that is not under our control. you know, so that's the investigator team that does that process, and they have that information, you know, and it's not important for us. How important for us is the data that we've received, and that we will be receiving in full detail at the medical conference. That naturally leads to the next question: When do you estimate the detailed data will be presented at a medical conference? You know, the only thing, that, we can disclose, because, again, this is the prerogative of the investigative team and Professor Åslaug Helland, is that they are targeting a major medical conference, and they will want to present again, because they think that is a very strong data at a very good conference. You know, we will be able to give inform you when they inform us which conference, they receive acceptance to present. Thank you. Next question: If you state that overall survival is the gold standard for these types of trials, why did you choose PFS as a primary endpoint? Jens, do you want to take this one? Yes. At the time this study was discussed, back in 2019, it was a very little information regarding the efficacy of CPIs in mesothelioma. It's important for us and for the investigators to understand as much as possible about the mode of action and also to have a speed in the trial. You will reach, of course, PFS before you reach overall survival. This was done to have a large or a lot of information on the patients within a relatively short timeframe. In this trial, as you know, the patients will be followed for three years for overall survival. You will have the same overall survival information in this trial as if the endpoint was overall survival. Since this is not a registration study, we have not now had the opportunity to have a readout of clinical data, unless we had to wait a bit longer for the overall survival to mature, as we are doing now after the readout of the PFS. Thanks, Jens. I will ask two questions that are closely related. Given how the study was powered, do you think that a statistically significant PFS improvement in the treatment group was likely? The second question, considering how the study was powered, could you discuss potential differences between statistically significant and clinically relevant PFS differences? Yes. In this area, in the mesothelioma area with CPI, there is no, at the point where this study was discussed, there were no randomized data that we could use to really understand how the CPIs are behaving within this cancer indication. We had, after a while, also information from first-line data. What you do, you go to the clinic and ask the investigators, discuss what is seen as a relevant clinical efficacy from a new drug, and then you need to work your way backwards into the phase II trial. A hazard ratio of 0.6 is something that is considered by the investigators and also accepted by the authorities when they approve this study to be a relevant level of the hazard ratio. As you know, in a phase II, the other statistics is not that tough as it will be in a phase III trial. A one-sided alpha of 0.1 and power of 80 is quite common in these trials. Based on a positive readout of such trials, either with the PFS here as a primary endpoint or even the gold standard endpoint, overall survival, this will be something that will give us confidence to move on in the mesothelioma trial. Thank you, Jens. Next question: How likely is it that patients will go on to try different treatments after progression? Assuming that some will, how do you view the overall robustness in the overall survival data going forward? Well, just to remind, in this indication, there has been first-line treatment with the chemotherapy only until quite recently. Over the last few years, we have seen the entrance of CPIs with the ipi-nivo, as you know, in first-line treatment, and also over the last year, where they combine CPIs with chemotherapy. For first-line treatment, there is established standard of care. In the second line of this cancer form, there is no obvious standard of care in the market. Most likely, patients receive palliative chemotherapy for several rounds, 1 to 3 rounds after progression, after first-line treatment. There will be patients that receive, of course, new treatment after progression in this study. We expect this to be distributed equally to both arms, so this will not impact how we evaluate the overall survival data. This is, of course, something that happened in all trials. Just as a reminder, this will be even more drugs if this was an earlier phase trial. In the end, I just want to say that you need to do overall survival to get the registration for the drug. It is understood and expected that patients will have been exposed to also other drugs after a trial is finished. Thanks. Next question, while you are not sharing any numbers, can you say anything about how large the difference between the two radiological assessments was? I think I answered the first part of that earlier on. I think we had a similar question. Regarding the difference, so what I can say again, or as much as I can say, you know, the rest is for the details for the when the investigators so decide, is that. We already said several times, if the study would have been measured in the primary endpoint under local review, would have been a very positive trial with highly significant statistical differences. You know, under central review, you know, we didn't meet the primary endpoint. The it's as much as I can say, you know, I can understand the curiosity, but that more details will have to be dependent when a lead investigator will decide to, you know, share that information. Again, as I said, their goal is to be presenting the strong data at the medical conference. Are you going to ask for a new independent central review? Well, no. What you do here, remember that what you're trying to do here is to really help patients that with a very severe form of cancer, you try to do that as objectively as possible. The central review is something that is predefined, how it should be conducted, you follow a lot of rules within the RECIST system to get the answers true. This is an independent review of the slides. In that word, it also lies that this is the view of that third-party vendor. It's also here conducted a local assessment of the images, which is different from the central review. Of course, in the light of giving as best diagnosis as possible to the patients moving forward, the group will assess and try to understand where the differences is, so that this can be discussed and developed further in the future. No new independent review, but there will be attempts to understand the differences in the review of the slides. Just to give another comment here, you know, the comment from the investigators is that they understand there's difference, but for them, you know, the important and for the authority is gonna be, you know, what is gonna be the final number or the more information on overall survival. Because, you know, reviews are a little bit subjective, depending on the radiologist, but overall survival is very clear, and really that's the part where they say so far is a very positive trend. For them, that information, overall survival, as Jens mentioned several times, you know, overlap, you know, overrides the PFS from the perspective of deciding the next step in the development of UV1 and the indication. Okay, thanks. Next question: Sorry, have you received any feedback from the checkpoint inhibitor sponsor, BMS, about this top-line data? The BMS was with us when the investigating team shared the data. We were, of course, present, and the BMS was also participating. The data was shared with both companies. Of course, you know, and we are talking about that, this was shared yesterday. You know, I'm sure BMS will do their internal review and process. I can just say the comment was that, you know, this is not unexpected. They have a lot of information, and as they said, also from the experience, PFS is probably not the best endpoint, but besides that, it's for them, and they will do the internal review. But they have the same level of data that we have. Yeah. Is the shown efficacy signal enough to initiate a phase III trial in this indication? Another related question, will you pursue a phase III in trial in mesothelioma? You know, we, the, there is confidence. The investigative team is very supportive of using this data to proceed. Of course, as a company, we, you know, we are positive about this data, but we believe, of course, that it makes absolute sense because, to wait for the presentation of the full set of data at the medical conference, because that's the data we will have to bring to the authorities to discuss the next steps in the development. For the time being, let me just say that there's no reason not to think that, pursuing mesothelioma, is part of our objectives. Okay. What was the separate predefined local assessment target compared with target for primary endpoint met? I'm not sure if I completely get the question, I guess it's around the statistics. The statistics, as mentioned earlier in this trial, was a hazard ratio of 6, one-sided alpha of 0.1 and a power of 80. This statistics goes for both the primary endpoint and an analysis around that endpoint. For the local assessment, it was the same statistics as for the primary endpoint. I think maybe just to clarify, because we get a lot of these different questions. As Jens mentioned, the statistics plan is the same. The images, the radiographic images are the same. The only difference is that where are the radiologists that assess those images? They are in a CRO, as a central review, or they are the specialists and experts in the hospitals that participate in the study. That's the only difference. Yeah. Was the central radiology review done at the end of the study, or was it done in parallel with the local review? For central reviews of the images, is taken at the different hospitals, of course, and then they are sent off to the third-party vendor. They have their internal setup, how to review the images, to get good quality on the results. This is an ongoing process throughout the study. It's also a process where the CRO, in collaboration with the study, ensure that they receive all the pictures taken from the patient, so they can have a, the full story about the images from each patient. This is an ongoing evaluation of images. Yep. Health Talk is basically stating that hazard ratio is 1 for the NEPER trial when saying experimental arm did not survive any longer than control arm. Is this correct? You know, Jens can comment, but I don't know. I have thought if first it makes that conclusion. How can they make that conclusion? Hazard ratio doesn't measure. PFS doesn't measure survival. I don't think if that even the question is correct or the text. Again, hazard ratio measures progression-free survival, the time that it takes for patients to progress or die. Overall survival is a totally different endpoint and assesses at regular points in times how many patients are alive in the different arms. The hazard ratio doesn't apply in this case as primary endpoint to overall survival. Jens, I don't know if you want to- I to just reemphasize what you said now. The statistics in this trial is for PFS, and that is the primary endpoint. After 69 endpoints, we have now had a readout of that with a different analysis, a central one and a local one, with different results. We do not have the numbers. Further, all patients in this trial will be followed over the next years for overall survival, for the overall survival data to mature, and that is what we are waiting for in this trial. Last, yesterday, we were informed that as of now, there is a positive trend in overall survival. The data need to mature to get a more statistic information on the difference between the 2 groups of patients. In reality, is the opposite, you know. Regarding overall survival, the information we have is that there is a quite an important positive trend in favor of the UV1 arm versus the control arm for overall survival. Thank you. Do you have any information on potential subgroup stratifications, for instance, PD-L1 status? Now, we do not have that information. It will be disclosed at the presentation at the conference in the future. Okay. One question: Can we expect the same kind of bad result with INITIUM? Sorry, can you repeat again? Can we expect the same kind of bad result with INITIUM? You know, first, you know, 2 comments. Again, we don't consider this a bad result. We consider this, and that the study did meet the primary endpoint from a statistical perspective, as previously defined. We believe that we have a good data shared with us by the investigators that are supportive. You know, INITIUM is in melanoma. It's a totally different type of tumor, totally different biology, you know, where clearly, you know, the checkpoint inhibitors have a totally different level of efficacy that is very well-defined. We have, you know, in mesothelioma, this was the first study that we did where we had information in mesothelioma, and again, in probably the most challenging group, that is the second-line mesothelioma. In melanoma, we have a very supportive information from the phase I. You know, we know that in INITIUM, treatment is having impact by delaying the progression or death in these patients. There's no... First, we don't consider this a bad result. Second, there's no, there's no way of moving these results again to INITIUM. As a matter of fact, we think that the data that we were exposed to, support to, and lead us to be more optimistic in terms the impact of UV1 in these other indications, and particularly the next one that we'll expect that is melanoma. Just to add a comment here. If you view the history of clinical trials in Ultimovacs, we have conducted several phase I trials earlier, and based on those results from those trials and information in the market at different time points, we selected as a company, malignant melanoma as our sponsored indication. Our lead indication here is malignant melanoma. Over the last years, we have presented Ultimovacs in different conferences and in different ways to different environments. We are very happy that we have received a lot of interest for the vaccine over the last years. In total, as you know, we are participating in four investigator-initiated trials. When we develop UV1, and I think this is important, we are of course, developing UV1 and hope that this will be of importance to patients. Right now, in the development of cancer vaccines, nobody has the full insight in how a vaccine work in connection with checkpoint inhibitors. As you can see from the different trials we are part of or sponsoring of, there is very different biology in different cancers. For the mesothelioma and the head and neck cancer, there is a low expectancy from the CPIs when it comes to efficacy for patients. On the other side, in non-small cell lung cancer and malignant melanoma, it's expected to have a huge impact to give CPI to patients. To really understand how a vaccine works when you combine that to the checkpoint inhibitors, we need to be in different biologies. For us, this is very important information to see how the vaccine behave in different biologies, difficult to treat patients like the mesothelioma and head and neck, and also how it works and what it possibly can add to already quite good results with CPI, for example, in melanoma and non-small cell lung cancer. I think it's important to reflect also on this. It's important for the development of the field and how the vaccine works to be brave enough to participate in different indications, which might not be obvious a home run in all indications. It will contribute a lot to the scientific community and hopefully for the patients in the end. Thanks, Jens. We have a question that is related to what you shared now. I will ask that. You can consider if there is something you would like to add on top of what you just said. Given that you say you will develop a universal vaccine, will you now put the ambition of a universal vaccine on hold? This is an interesting question in a way. When we are saying that a telomerase vaccine is an universal vaccine, you can view that from different angles. One angle is that, is this an antigen that is relevant for different indications for patients with different forms of cancer? To that, we can answer yes. If the immune system get interested in telomerase as a target, this is a relevant target in 80%-90% of all cancer indications. When it comes to stage, these days, there's a lot of discussions around earlier stage of treatment versus later stage of treatment. The telomerase expression as such, is something that starts to express telomerase early on in the cancer development, and it's present throughout the course of the cancer. You will see expression of telomerase from early stages to late stages, both in the primary tumor and in the metastasis. Another way to look at the universality of this vaccine is to look at who can get this vaccine. In the telomerase peptides, there is several different epitopes that can be recognized by different HLA classes around the world. We have looked into this, and we believe that this has a global coverage. We do not do any HLA screening of patients prior to inclusion in studies, and expect a good immune response in different territories. Just a reminder, in our earlier trials, we had an immune response between 80% and 90% in the different phase I trials. When it comes to the clinical universality, that is a different question. Imagine that the vaccine, the mode of action of the vaccine is that it add effect on checkpoint inhibitors, right? For example, in melanoma, you expect a response rate in patients around 50%. 50% of the patients will, when they receive checkpoint inhibitors, they will have effect. What is that effect? The effect is that the CPIs is opening the tumors and the draining lymph nodes so that the pre-existing immune system can kill the cancer cells. If the checkpoints were effective for more than 50% of patients in melanoma, it is likely that also the immune system could have an effect on those patients. Putting this into context, it's actually two different mode of actions here. One is the vaccine mode of action. We are injecting the vaccine, we are generating T cells that are designed to kill off the tumor cells in the end, but these T cells need to have access to the tumor. Therefore, you combine with checkpoint inhibitors so that the T cells can enter the tumor and the draining lymph nodes. This is one part that could be discussed when it comes to universality, but the universality also lays on the checkpoint inhibitors. We do hope that in the future there will be a development of even new checkpoint inhibitors that open the tumor for the immune system in even more patients. As we have stated over the last years, we see the CPIs as our collaborators. We want to combine with different CPIs that show this effect, that the tumor is opened for the immune system. Another mode of action, just a very short at the end here, is that there's something that we call the cold tumors. That could be different things, but if you define that as a tumor that does not respond to the CPIs. This is also an interesting area for us to understand if a vaccine, for example, the UV1 vaccine, can change the microenvironment in these tumors so that also these patients have efficacy from the checkpoint inhibitors. As you might remember from the 103 trial, we have just presented data on that one. We saw in the overall group and in the group that were PD-L1 negative, the same results. We acknowledge that that was only 30 patients. That is the kind of information that is important for us moving forward. In the mesothelioma trial, which is the trial we discussed today, there is a very small group of patients that respond to CPI, meaning that there is a small group of patients where the immune system get access to the tumor and have clinical efficacy. For most patients within mesothelioma receiving IPI-NIVO, they will progress immediately because the IPI-NIVO have no effect on those patients. What we try to understand in this study is also if the vaccine on top of IPI-NIVO can move the patients from being irresponsible, don't respond to the CPIs to be responders, when you add the vaccine on top. It was a long answer to that question, but this information is the reason why we are in the different indications. We want to explore the mode of action, in different biologies, as I stated, earlier. I also want to take the opportunity to clarify some misunderstanding, because the question, you know, makes the assumption that we consider mesothelioma as a failed indication, that we miss an indication. That is far from being true. You know, the fact that, again, let's remind this is a phase II study. PFS is just the primary endpoint, and it's not the full information of the study. As I mentioned, based on the information that we have, and that, of course, we will have full detail, you know, later on, there's no reason not to think that mesothelioma is a valid indication to further develop, using UV1, but of course, most naturally in first line. I want to clarify that from our perspective, the fact that we didn't meet the primary endpoint percent review doesn't mean that this is a failed study. On the contrary, we think that the data is quite supportive for mesothelioma patients and also for giving us additional information for the rest of the program. Thank you. Next question: Could you comment the data from the KEYNOTE-483 study, which MSD released in March? Does this result have any impact on the further studies with UV1 in mesothelioma? As I said earlier, there are over the last few years now, this field or in patients with mesothelioma that earlier were treated with only chemotherapy, now have access to CPIs, first with the IPI-NIVO trial, and different companies now develop the CPI in connection with the chemotherapy. We have seen some of these results now recently, and it seems like the IPI-NIVO combination and the CPI chemotherapy options have roughly the same overall survival in these patients. There are still some results to wait for in this field and how it will end up, what will be the standard of care, is as of now not completely understood. One thing that is certain is that in this field, moving on, there will be CPI for patients, meaning that the immune system will be involved in treatment of these patients. In this field, even if it's very early, there's also discussions how to move the treatment earlier. There is also a lot of initiatives where they test the CPIs in the adjuvant or neoadjuvant setting, the most. CPIs will be around. What the standard of care will be in the near future is still to be decided, but it's obvious that they have moved away from only chemotherapy for these patients in the society. Of course, you know, this expands the potential for UV-1 to have more combinations. As Jens mentioned, you know, the more the CPIs are used, you know, the more we see opportunities to use UV-1 in combination with CPIs. Thanks. A more specific question. Only a tiny minority in the market has acknowledged that the threshold for reaching the primary endpoint in NIPU was a hazard ratio of 0.73. Would it not be relevant to state this number in the press release? Jens, you are on mute. Yes, I saw that. Sorry. The statistics in this trial, and I'm not a statistician, just to be precise on that. As I have mentioned earlier, the theoretical statistics, the background for these studies, is this alpha 0.1 power 80 and hazard ratio of 0.6. When you then start a study, and then look at the results afterwards, if you are below 0.736 in these trials, you will have a positive trial study, meaning a p-value below 0.1 one-sided alpha. I do think that we have mentioned this in some earlier presentations, but yes, this is something that we will bring on further in presentations. Thanks. At which medical conference is the principal investigator aiming to present this data on? You know, we are not at liberty to disclose that. That is really, a decision and responsibility from the lead investigator. You know, when the Professor Åslaug Helland wants to disclose that, she will do it. The only thing we can tell is that they really target a major medical conference. Thanks. The interpretation of primary endpoint met at the local hospitals, is that point of view shared by all hospitals taking part in the study? What happens with the local assessment? In the local assessment, the images taken at the hospitals are reviewed by the local radiologist at these different specialist centers, and they are informing on their results in the database. When all information is in the database from all images, this information will be used by the statistician in the study to calculate the different information needed and the primary endpoint. There is no discussion or review across the different hospitals to understand if they have the same view on the pictures. This is a result where the different hospitals contribute with the data, and afterwards, that data is calculated and endpoint presented, as we have done. Thanks. Next question. Commenting on the statement that this does not need to be the end of UV1 in this indication, what can we expect in terms of time before decisions on the way forward will be taken? Also another question that we can add, it may have been answered, but at what time can we expect to have these more mature data presented? I think we already addressed that. You know, basically, investigators, again, as I said, they believe that they have very strong data. They want to present it at a medical major conference. You know, I'm sure they don't want to spend too long on that. What I can say is that, you know, although we are positive in pursuing the indication, of course, we need to wait for that data. A decision and the plan to move forward is gonna be dependent on us having access to all that data to share with the authorities and discuss the next phase of development. You know, one way is linked, one decision is linked to the other. Again, you know, their plan is to present to as soon as possible at a major medical conference. Okay, next. As 69 patients have had progression, what would be a good result for this population in terms of progression per arm? Specifically, would 30 progressions versus 39 be seen as a good result? Well, we have discussed this also earlier. Just a few words on the statistics in these trials, both in the NIPU trial and in the INITIUM trial. What is done here? You use historical data. It was not that much historical data in the mesothelioma space in second line when we started this trial. You use historical data to try to get a grasp how many patients is needed in the study. Based on what you, the investigators or us in the INITIUM trial, decide as a relevant hazard ratio target, the number of patients is calculated. You need to decide how certain you will be about the result. If you have tough values, you need more patients. In a phase II, the statistics we have, is a common statistics in trials. You start to try with the two different arms, you wait for those endpoints to occur. In this trial, 69 endpoints. It's the area between the curve, the Y-axis and the X-axis, versus in the other curve, Y-axis and the X-axis. That is in a way, defining the hazard ratio in the study. Two things are important here, because I have seen a lot of discussion around how many patients do you need in the different arms. There are one more thing that is important, and that is the time to progression. The time to progression will impact on the area under the curve, so it's both the number of patients in each arm, but also how long it took for a patient to progress. In extreme circumstances, there don't need to be too many patients difference between the 2 arms if they progress at very different time points. Okay, thank you. We are now running out of time in a few minutes, so we just have a couple of questions left. One question I would like to comment on myself as CFO, it reads: The stock price is down over 30%. Do you think this is an overreaction? As a general comment, we never will make comments about the share price of Ultimovacs. We don't have any comment on that. The next question, there are two different questions on the same topic. Have you reached 70 endpoints in INITIUM by now, or are you still waiting? Another one, can you inform about the number of events by now in the INITIUM study? You know, as informed, you know, we will keep all the market updated regarding the INITIUM at different points in time. We are not going to disclose at this time any information about that. We maintain the previous information that we expect the top line results for the INITIUM study to come in the second half of 2023. If at any point in time, we believe that there is enough information to change that guidance, then we will inform the market accordingly. Thank you. We have a last question. Is it possible to explain more about why these NIPU results are also positive instead of focusing on the differences between local and central review? The most important endpoint for these patients is, of course, survival. That you treat the patients so that they survive for a longer time, and that is the most important thing, and that is the ambition in all cancer development, to keep the patients alive. PFS in this study is a surrogate endpoint that is there to. If you see an association between improved PFS and overall survival, we'll inform on overall survival for doctors and in future clinical studies. The PFS is an important endpoint. The overall survival is even more important. What we see in this study is that there is a trend, a positive trend in the this study for overall survival in the arm with patients that receive UV1, ipilimumab, and nivolumab. As you recall, the last patients were included in the study just months ago. In January was the last patient enrolled. This data need to mature somewhat longer to get a good understanding of this trend. This is something that we see as positive, that this is data to us from the investigators, that they see this positive trend, and we are encouraged to follow over the next time to see how this develop. Also, for the PFS, the primary endpoint was negative, the local assessment was positive. That's, that is a pity, and it is, of course, somewhat harming the development in the short run. We believe that in the long run, when this data mature, we can take a good decision. To move further on into phase III and development in this indication, we would have needed overall survival. Also, in that circumstance, we would never start a phase III trial based on PFS data only. In a way, we have got more information on the overall survival. We know that there is a trend now. We didn't know that a few days back. Yes, it's a pity that the primary was negative, but, in the long run, it's the overall survival that we need to have there to make a decision for the further development. We are, at the moment, positive about the information we have received. Thank you. There are no more questions, and we, it's 11:00 A.M. Okay. Thank you, Jens and Hans, of course, thank you, everybody, for your attention, all your questions. I just want to leave you with a positive message from us. You know, we believe that this data from a clinical perspective, from an impact on patients, is a positive data supporting our program, we look forward to continue updated on the development of UV1 and the other programs. Have a great day.