Ultimovacs Asa

Good afternoon, good morning, or good evening, depending on what part of the world you are listening to us. And we want to thank you for taking the time to listen to the UltimoVax second quarter 2023 results. As usual, I have with me Jens Bjornheim, that is our chief medical officer, and Hans Vasco de Eyde, that is our chief financial officer. I want to remind again everybody that you can use the system to put questions that we will try to answer as many as possible after we cover the presentation. And with us, briefly moving to the next slide. As a publicly listed company, we need to show you the disclaimer. And moving to the next slide, and just for the benefit of the ones of you that are not so familiar with UltimoVAX, just briefly tell you in summary what do we do. We are a clinical stage biotech, and we are developing a universal off-the-shelf cancer vaccine in quite a broad clinical program, as you will see. We have, as I mentioned, universal off-the-shelf cancer vaccine that targets telomerase. Telomerase is expressed in 85 to 90% of cancer types throughout all stages of the disease. And because it's essential for the cancer cell survival, it's also difficult for the tumor to escape the immune response. The vaccine is easy to use as intradermal injections. And as you will see, and we try to prove, has the potential to be used across multiple cancer types and in combination with different immune modulators. We have an excellent clinical trial execution. Currently, we have one phase one and five phase two trials ongoing and multiple phase one studies now in long-term follow-up. We have shown so far quite a strong safety profile, clear signals of efficacy, and also durability of immune response. Some patients still show immune response more than 10 years after being vaccinated. We are really approaching near-term very key value inflection points for the company with data from three randomized phase two studies expected within the period of one year with the first ones coming now in the fall of this year. We also have strong external validation by we received fast track designation, orphan drug designation in metastatic melanoma by the FDA. And also because we, as you will see, we have several projects that we collaborate with big pharma companies in our extensive clinical program. And we can see that in the next slide. So Jens will cover the details, but here I just want to highlight because it's really rewarding and the recognition of the dedication and excellent execution by the team that every quarter we continue to show that we are completing enrollment in our studies. And of course, as you see there, particularly the ones from phase two, that is the INITIUM, the NIPO, and the FOCUS study, you know, this is more important to emphasize that two of these studies started to enroll at the beginning of the COVID pandemic, and FOCUS also during the pandemic, and despite of these challenges, you know, we have been successful in completing enrollment of these patients. We will talk in more details, Jens will cover this, but I also want to emphasize here that what I mentioned that in two of these studies, in the NIPU study mesothelioma, we cooperate with Bristol-Myers Squibb, and in the ovarian cancer study, the DUVAC study, we collaborate with AstraZeneca. In addition to the program with UV1, our lead program, we also have an adjuvant technology platform, the TED platform that we have currently in phase one studying prostate cancer. And we will also give you a little bit more details during the presentation, but particularly we are planning a good information to the market towards the end of the year. So if we move now to the next slide and talking about this quarter, Again, from our perspective, another very successful quarter for UltimoVAX. I think that the major program, the clinical study where everybody is really keeping a close attention to is the INITIUM study. The INITIUM is a study where we treat patients with unresectable or metastatic malignant melanoma. And in the study, we have enrolled 156 patients. The study will stop to analyze the data when 70 patients have progressed or died. Very positive for these patients, this has not yet occurred. So we don't have yet 70 patients that progress or died. What of course is very positive for these patients. But the consequence for us is that we had to change the guidance where we were expecting top line results. from the second half of 2023 now to the first half of 2024. One of the things we are observing is a slow progression of new events or deaths. So taking this into consideration, we are internally discussing alternatives to approaches to do data readouts. We discussed this with our advisors, and of course, any activities will have to be shared and agreed by the health authorities. But we think this is important as a company to be prepared when we observe this slow progression of number of events. The second study, the NIPU study in malignant pleuromesotelioma, We had some results presented earlier where, as you know, we didn't meet the primary endpoint. It is hazard ratio pre-EFS when the images were analyzed by central review. When the images were analyzed by the radiologists at the hospitals, then we clearly met the primary endpoint of HRPFS. And also, you know, this difference between the two arms was statistically significant. But again, Jens will cover this in more detail. Very important for us was also we saw some improvement and some difference in the overall survival between the two arms in favor of the UV1 arm. Of course, this data was still not mature enough. These patients have continued to be followed. And the lead investigator and her team and the other investigators are now updating all this data. And full details will be presented, including overall survival, at the medical conference before the end of the year. So very exciting period. We are all really looking forward to receive the details of what we believe are quite exciting preliminary results. Very pleased also to have concluded enrollment in our third phase two study, the focus study in head and neck cancer. In this study, different from the other ones that are event-driven studies, we, the investigators, we look, it's a landmark study, what is called landmark study, and the data will be analyzed 12 months after the last patient was enrolled. And so the investigator then will communicate to us, particularly PFS and overall survival, after a minimum of 12 months follow-up. So this is expected in the second half of 2024. From the financial perspective, that will be covered in detail by Hans. You know, the main update was that now we changed guidance from a financial runway from mid-2024 to the second half of 2024. And the important thing to emphasize is that basically this runway will take us through the results of these three studies that we just touched bases, Initium, NIPU, and FOCUS. So if we move to the next slide, because a lot of other things happened during this quarter that we are also very proud of, that are not just related to the main studies. I think an important milestone for a biotech is that we have now more than 300 cancer patients that have received treatment with UV-1. And very important, as you all know, because safety is extremely important when you use combinations, UV-1 to date has no safety concerns in these more than 300 cancer patients. So a very important milestone for us to pass this to 300 cancer patients that receive treatment. The UV-103 study in melanoma in combination with pembrolizumab continues to deliver data We received very strong survival data, three-year survival data for the UV1-103 study, as all patients in the cohort two that were alive after two years remain alive after three years. So again, this is a trend that we continue to see an impact of UV1 in extending survival in these patients. We also continue to put a lot of efforts by the team and publish the data. This is very important to raise visibility of UltimoVAX and the science and the results to the medical community, scientific community, but also to the pharma community. And we publish in a very reputable journal, the Clinical Cancer Research, extensive results in clinical and biomarker analysis of the data from the 103 phase one trial. Also, extremely important for a biotech company, we continue to expand on our patent portfolio, similar to the grant that we received in the US last year. We receive now granted patents in Europe and Japan that protect UV-1 in combination with checkpoint inhibitors. until at least 2037. And then, of course, there will be post-extension. So very important that a great effort by the team to continue to strengthen our patent portfolio that, as you know, is extremely valuable on the valuation of the company in any discussions of a partnership with Big Pharma. We are also very pleased that our chief scientific officer, Gustav Godernak, that, as you know, is also one of the inventors of UV-1, was awarded with the Norwegian Tech Awards Honorary Prize as an outstanding pioneer in the fight against cancer. We are not surprised. It's a very well-deserved award to Gustav. And again, we as a team hope that this will be the first of many other awards that Gustav we'll receive as we progress and we start to get the data. As I mentioned briefly, Ultima Fox is not just UV1. We have our TED technology, adjuvant technology. In addition to the Tendu study, that is the part that is more visible to our listeners, we also have been doing extensive work in preclinical and CMC studies. And we plan to give a little bit of an update to the market on the overall TED platform technology, including the Tendu study that is one part of the overall program. And we plan to do this towards the end of the year. So with this, moving to the next slide, I give the word now to Jens. Jens?

Thank you, Carlos. Good morning and good afternoon. The first slide in my part of the presentation gives you an overview of our clinical trials in phase two. For your benefit, just a few comments around these studies. As you can see here, we are in five different indications. This is different cancer forms with different biology, and also cancer forms that are treated with different drugs. In all these indications, telomerase is expressed and we combine with what is the standard of care as of now. So for the NITIM and NIPA trial, we combine with ipinivo, as you know, in the head and neck cancer focus with pembrolizumab, in ovarian cancer with durvalumab and olaparib, and in lung vac with semiplimab. For these studies, three of them, as Carlos mentioned, they are fully enrolled. The initium study was fully enrolled last June, and I have expected top line readout now, first half of next year. For the NIPA trial, we had some of the data presented in June this year, and the rest of the data is expected in fourth quarter this year. And for the FOCUS trial, which is a landmark trial, All patients were included in August. So the inclusion took two years from August 21 to August 23. And we will wait 12 months to have 12 months information on all endpoints. And there will be a readout of this study second half of next year. The studies has been and will be also to recruit the rest of the patients conducted at sites in the US, in Europe and in Australia. On the next slide, you can see an overview of the current inclusion in the different trials. So for the three first, they are completed with enrollment. the DOVAC trial in ovarian cancer patients. It's now 37 patients, up from 24 in the previous quarter report. In the LUNGVAC trial, 11 out of 138 patients are now enrolled. These two trials are still in early days, so we expect the inclusion of patients to increase over the next period. The TENDER study with the TET platform was fully enrolled earlier this year, and we expect a readout of that one for the quarter this year. On the next three slides, we have some comments to the fully enrolled trials. The INITIUM trial is a trial in unresectable or metastatic melanoma. This is our sponsored trial. We enrolled 156 patients from 39 sites and 40 hospitals in the US, UK, Belgium and Norway. The first patient was enrolled in June 2020 and two years later in June 2022, all of the patients have been included in the trial. As of now, all patients in this trial has been followed for longer than 12 months. And we mentioned this due to the fact that the historical studies that we are used to design this study, and which is also in a way the benchmark for ipinivo, and checkmate 067 and checkmate 511 trials. Both of them have a medium PFS that is between 9.5 and 11.5 months. So as of today, all patients in this study has been observed for at least 13 months. In this trial, there is an endpoint-driven design. This means that it's defined prior to start of the study, how many patients that should have an event, meaning progression of the disease or death. In this study, it should be 70 cases before the database is closed and the calculations are done. In April this year, we informed the market that we hadn't reached 70 events in this study, and we also today informed the market that 70 events have not been reached in this study. Therefore, we extend the readout to the first half of 2024. As you know, in checkpoint inhibitor treatment, there is a plateau and most of the patients have now reached this linear plateau in the Kaplan-Meier curves for PFS. So we expect slow progression of new events over the next period of time. We will have already started internally to explore alternative approaches for data readout. And we will, of course, in due time, discuss with regulatory authorities how to proceed with the closing of the database and readout of this trial. On the next slide for the INITIUM trial, This is an investigator-initiated trial led by Oslo University Hospital. The trial is supported by us with the vaccine UV-1 and from Bristol Myers Squibb with IPI and NEVO. The study enrolled 118 patients from six sites in the Scandinavian countries, in Spain and in Australia. First patient were enrolled in June, 2020, and the last one was enrolled in January, 2023. In June, we had some information from this trial. The primary endpoint in this trial was defined as central review of images and death. According to central review, the study was negative. As a test of the primary endpoint, also other ways to assess the images are done, and one of them are local assessment of the images. This is something that is predefined in the protocol prior to the start of the study. By using local assessment to review the pictures and images, the study was positive. And by positive, we mean that according to the statistics in the study, which has been disclosed earlier, with a hazard ratio of 0.6, one-sided alpha of 0.1 and a power of 80, this study was statistically positive. Also in the June results, we saw an interesting trend in overall survival with a clinical relevant difference between the arms in the Kaplan-Meier plot, but still the data in mature to conclude. So over the months now, we are waiting for the overall survival data to mature. It is expected that the top-line data, including updated overall survival data, will be presented at a medical conference in the fourth quarter this year. On the next slide, regarding the FOCUS trial. This is an investigator-initiated trial sponsored by Halle University Hospital. This is a hospital just outside of Berlin in Germany. And this is a German trial, 10 sites and 75 patients have been enrolled in this study. Enrollment took two years from August 21 to August 23. Different from the other four phase two trials, the focus trial is a landmark study. So the primary endpoint in this study will be PFS as at six months. To relate the PFS and the other endpoints in this study, all patients will be followed for 12 months. And after 12 months, there will be a readout of all endpoints, both the primary PFS at six months and also all endpoints at 12 months. These top line results are expected in second half of 2024. I guess when we move on to the next slide now, Hans will say a few words about the financials.

Yes, thank you, Jens. I will proceed with the key financials. Move to the next slide. So by the end of the second quarter, we had a total cash holding of 344 million NOK or around 32 million US dollars. And as Carlos also stated, we have now revised the expected financial runway. We have up until now guided a runway to mid 2024. And based on updated projections, we are now changing the guidance to the second half of 2024. This means that we will have funding through the three first important readouts in the Phase 2 trials, more specifically the reporting of the overall survival data in NIPU later this fall, and the top-line readouts in NISM and FOCUS. The basis for the revised and extended runway is that Some cost elements are coming later than previously anticipated. We have not made any specific cost cuts, but have been somewhat conservative when estimating the runway earlier. And generally, we have a cost-conscious approach internally, which makes us able to capture certain cost savings. Looking at the key financials, the EBIT or the operating profit for the second quarter, we continue, of course, with the operating loss at this stage. And we had a negative operating profit of minus 51 million NOK in the second quarter. For the first half, we had operating profit of minus 101 million NOK. And looking at profit before tax, for the quarter, we had a negative profit of minus 43. And for the first half this year, minus 77 million NOK. If we look at payroll expenses specifically, the underlying salary expenses are fairly stable from quarter to quarter. But there are some significant quarterly variations in total personal expenses due to the share price-driven allowances related to the share option program. This is fluctuating with the development in the share price. And in the second quarter, we had a drop in the share price. And this implied that we had a negative cost element of around 6 million NOC this quarter. So without this change, this element, the cost would have been six million higher, just to be clear on that. Looking at R&D and IPR expenses, these are significantly higher than the previous quarters, driven by clinical trial activities and manufacturing, also called CMC activities. This is, as we have guided for quite some time now, that the R&D expense level will increase from the previous levels. So going forward, we should expect the operating expense levels to continue at a fairly high level, as we have seen now for the last couple of quarters. There will continue to be quarterly variations, but this expected expense level is driven by the further progress in the phase two trials, in the CMC development, and in other R&D activities. Being mindful of time, I will not go into detail in this presentation. As always, we have included more detailed slides on the key financials, including quarterly breakdowns of cash flow and P&L. But we would like to prioritize time to Q&A. So if there should be specific questions, please do not hesitate to contact me after this presentation, if you would like further details. So with that, we will skip the next couple of slides and move to slide 18, and I will give the word back to Carlos. Thank you.

Thanks Jens. Thanks Hans. So if we move to the next slide. So let's talk about the exciting period ahead for Ultimofax. You know, we continue to deliver as promised, and we have some important data as discussed so far coming, you know, very short. The first one will be the four-year overall survival in the cohort one in the 103 study, you know, that I remind, you know, in the second cohort, again, the patients are still alive after 12 months. Of course, probably the highlight of the data during this year is going to be the full data that will be presented at the medical conference in the fourth quarter on it. This will have full details of the study, you know, of course, PFS, overall survival, details on patients, and a lot more details. So we're really looking forward to that. And as I mentioned, you know, towards the end of the year, we will update the market on the TETs. technology. Then, you know, for next year, we will continue with the additional data, you know, now initial move to the first half of 2024. We will also have towards the, you know, towards the June, July timeline, four-year overall survival on the second cohort, and then the five-year survival on cohort one. And of course, as mentioned, also the data expected in the second half on FOCUS. At this moment, you know, we are not giving any updated guidance on Duvac and LungVac. As Jens mentioned, these are early stages. We are happy to see a ramp up in the recruitment of patients, but we feel that, you know, a better guidance will be provided with the Q4 2023 report. So if we move to the next slide. I want to highlight that we continue to, as a company, to try to be as close as possible to our shareholders and supporters. And so far we have been having successful meetings in different Norwegian cities. And the next ones will be the day after tomorrow in Trondheim, where Some members of the team will be there in the evening to meet as many shareholders, interested investors, anyone that wants to meet the team and find out more about Ultimovacs in a more relaxed atmosphere. So if you are interested, you still can register and go to the website or send an email to ir.ultimovacs.com. So before we move to the Q&A and moving to the next slide, just in summary, you know, we have what we expect to be a transformational year ahead of us, waiting for data from three phase two trials in different cancer indications and in tumors with different biologies. Very positive for patients, melanoma patients. It's taking longer for them to experience this and progress or die in the initial study. So as mentioned already several times, we continue to wait for the 70 events. And this extension of the deadline is in terms of when we expect results as minor cost implications. But as mentioned, you know, and as a responsible company, we have been discussing alternative approaches for data readout that then, of course, will have to be discussed with the authorities as we continue to see a slow progression. We've really worked very excitedly the data, particularly overall survival from Nipu in the fourth quarter of this year. And, you know, we, in anticipation of positive data, we are already preparing for discussions with the regulatory authorities immediately after the data is available in terms of what will be the next step for the development of UV1 in mesothelioma. We continue to strengthen our patent protection now with the combination patents granted in Europe and Japan. We expect to give you an update on the TET platform overall, including Tendu, before the end of the year. And, you know, we have a financial runway that takes us through the results of three studies. And as I mentioned, you know, we want to thank you for your support and excited to during the next 12 months to share with you all the data that will be available. And again, what we believe is a transformational year for the company. And with us again, I thank everybody for your attention and we can move now to the Q&A part of the session.

So Hans, thank you. Thank you, Carlos. Um, we have, as always received several questions, uh, in particular related to initial and NIP. So, uh, I think we can kick off with some initial related questions. Um, we can start with the following, uh, at what point would you consider looking at the initial data, even though 70 events has not occurred?

You know, this is more than when we consider looking at the data. It's more that we need to look at all the pros and cons and all the alternatives. But the primary decision is going to be discussions with the authorities, as I mentioned, if we continue to see this slow progression. As a company, we cannot do anything as to be any suggestions, alternatives will have to be discussed and agreed by the authorities. So that's the key decision point, that the authorities agree to any alternative ways of looking at the data.

Another question, what alternatives do you foresee in case the initial study will be stopped before 70 events are met?

You know, at the moment will be too premature to be discussing those, and that's that's the process we are now currently internally and with our advisors looking at. So as we continue to have more details and if we see that there is a, you know, a reason to update the market, then we will of course continue to update our our shareholders.

Yeah. Then a question, how many events do we have in the initial study by today?

We, we, you know, the information we can provide is that we don't have yet 70 events and that's the, and that's how we will continue to inform the market is if we are not reached the other 70 events or when we reach the 70 events.

Thanks, Carlos. Another question. If INITIUM gets delayed further, could it be one option to include the patients from the additional study that followed INITIUM as opposed to readout with less than 70 events? Jens, do you want to address that part?

At current, the INITIUM study as such is fully recruited and designed with a number of patients that have been included in that study. So the study design itself is there. So that will not be a part of the discussion with the authorities. It will be, as Carlos said, if there are ways to analyze the data in a different way. But this is too early to discuss right now.

Yeah, so the extension study, these were not randomized, so these patients are going to be very important to give us a lot of information mechanistically, of course, in terms of efficacy, but not to be part of the analysis in initiating.

Okay. Then I will try to shorten a long question related to this potential alternative approach to readout. The question is, could the independent data monitoring committee or the ethical committee have a role to play in a potential earlier readout before you have the 70 endpoints? And to what extent is the ethical committee having access to data during the trial. Janus, do you want to start there?

Yes, so when you start the study, there will be a process where you are in contact with the ethical committees at different sites and in different countries. They are approving the study according to different ethical standards that must be fulfilled. And they are also concerned about the safety of patients in studies. When they approve the study as such, they have no direct interaction with the data or development of the study. To expand a little bit on that, so in connection to all studies, there is so-called independent data monitoring committees. We do have such shown in the INITIUM trial. The IDMC, which is called, I have regular meetings where they receive all the safety data from the study. More frequent data in the beginning and then longer intervals when the study progresses. This group only look at the safety. So this is a part of the big discussion. It could be that such group can also look into efficacy data, but as we have stated, this has not yet been discussed fully internally, and also it needs to be discussed with the authorities.

Thanks, Jens. Another question. This goes to Carlos, I assume. In the introduction, you say that one of the things that you see in the initial is slow progression on the number of events. Does that mean that there are other observations of interest? And if so, can you elaborate?

No. As it's clear and we have been transparent, we don't have any access to the data. We continue to be blind to the data. The part of data that we receive is, of course, if patients die and how the number of events progress. So the part that we can observe is that, as Jens mentioned, and it's not unexpected, is that after some time you start to get this plateau in the Kaplan-Meier curves in terms of survival and in terms of PFS. So that's as much information as we have.

Thank you. And then a specific initial question, I guess, goes to Jens. Related patients lost the follow-up or retention rate. Do you know what the retention rate in Inisium is? Is it as expected?

Well, I would say that this question is part of the clinical data set that we will one day see. So we don't have this information as of now, and I cannot comment on that further.

Okay, thanks Jens. Moving over to NIPU. Is it possible to elaborate on what sort of data the NIPU team and the principal or the principal investigator, Professor Helland presented to the company and BMS? And if possible, can you comment on whether BMS as study sponsor has had to access to further data under NDA?

You know, as previously communicated, the set of data was shared with both Ultimavax and BMS and, you know, at the same level. And, you know, the detailed data will be available to both companies, us or BMS, when the investigator has it and, you know, after presented to in the medical conference. As mentioned, we had access to some preliminary data in terms of events and in terms of survival, as was already mentioned before and now also by Jens. So that's the level of data. So we don't have full details on the study. even if preliminary in June, but we got the data that showed again that we didn't meet a primary endpoint in the central review. We clearly met the primary endpoint in the local review with statistical significance. And as Jens mentioned, there is a difference within benefit in terms of officer arrival in the UV-1 arm, and that's the level of data that was shared with us. We also, you know, cannot as a company, you know, expect the investigators to provide more because they are still now further analyzing the data and getting more mature data. But the data was shared with both companies and at that time when we communicated and now, you know, when the data will be presented at a medical conference.

Thanks. Next question. Regarding NIPU, you're right that a significant positive PFS outcome was measured in the onsite analysis at all five study centers. I have two questions. First, what level of significance are you referring to? Is it a study design or a one-sided alpha of 0.1 or two-sided 0.05? And second, Are the results from the five different sites significant by themselves, or are you referring to five identical conclusions of the aggregated results? Jens?

Yes, so the statistics we are referring to is the predefined statistics in the NIPI trial with one-sided alpha of 0.1, power of 80 and a hazard ratio of 0.6. With central review, the primary endpoint was not met according to these statistics. With local assessment, the statistics were met. It was a positive trial. When it comes to the data for such a study, I would like to comment on how this is working. You have the database and you have a page for central review. When the radiologists at the central review are receiving the images, they are filling in the necessary data on that page in the database. For the local assessment, the same thing is done. So they have the same page and they are filling in their numbers for each individual patient. Over time, every number should be there. And when everything is in place in the database, the database is locked. So there are two sets of data, one for the central review and one for local assessment in the database. And then the database goes off to the statistician, which is a different entity and different person, calculating the results from both the central review and the local assessment. So there is no local calculation of the data on each individual hospital. This is done by one statistician after the database is looked.

Thanks, Jens. um yes next question why was pfs the primary endpoint for the phase two mesothelioma trial given there aren't multiple lines of therapy and yes a survival to complicate measuring over survival for this disease in fact it's important to remember that

In phase two, you want to gather as much data as possible so you can set up the most perfect phase three trial positive when you are really validating if your drug has a value and giving it to people as a standard of care. So PFS at the point where we started trials with the UV1, it was recommended by the FDA and the authorities to have PFS as a primary endpoint to understand how the association between PFS and overall survival was in that indication. So at no time, PFS has been seen as an endpoint that will lead to the decision if you want to move on to phase three or not. It will always be overall survival. That is the no-go for phase three development as such. What is important with PFS then is that if there is an association between PFS and overall survival, you can save time, you can save money, and get the drugs earlier to patients. Unfortunately, in the NIPA trial, since we have two conflicting results on the PFS, we do not know if there is an association between PFS and later positive overall survival. This is something that is seen in some indications, especially in those indications where the PFS is very short as in head and neck cancer and in mesothelioma.

Thanks, Jens. Then a very specific question here. Is it true that you cannot answer if you have seen the HR values or the observable graphs in IPE? I also want to know if BMS has seen it or not.

I think we already answered that question. We had access to the data, and the same set of data was shared with both sponsors, Ultimavax and BMS. Thanks, Carlos.

Then, also related to NIPO and Mesothelioma, could you quantify what you think the market opportunity in Mesothelioma is? Do you see this more as a European project, given the low incidence in the US?

No, as a matter of fact, we see this as a global project. And I think there's a misunderstanding, because Mesothelioma is quite prevalent in the US. as a matter of fact, has become extremely visible in the public eye and in the media after September 11, because there was a lot of asbestos in the Twin Towers and a lot of the first responders, being firemen, police and their families, were unfortunately contaminated by these asbestos dust and develop mesothelioma. In the US, it's very visible mesothelioma and very strong patient associations. So we see a global value for UV1 in mesothelioma worldwide. And of course, more important than everything is that For us, NIPO is going to be the first study that is going to show if telomerase is a valid target, and particularly in a very, very extremely difficult population to treat, because second-line patients with mesothelioma have basically no treatment alternatives. and progress and die very fast. So any positive results here are very supportive of the concept of UV1. But as a disease itself, we see a disease with very high, very high need, and also that at the moment is recognized as an orphan disease. So also with some advantages there. So we can, from our perspective as a strategy, positive data from NIPO study supports moving into registrational studies in the syndication.

Thanks, Carlos. Next question. Do you have an NDA with any company at this moment?

You know, we cannot, we are not going to share. We have discussions with different companies and this is part of the normal process. In some cases you have NDAs with other ones not, but this is is part of the normal process that you have different types of discussions.

Then we have a question related to possible new clinical trials. Could a phase two randomized clinical trial in non-small cell lung cancer in combination with chemo and Keytruda happen? Jens?

Interesting question. So, as you know, We have said several times that we follow some rules, so we need to be in an indication where telomerase is expressed. That is true for non-small cell lung cancer, so that is fulfilled. The other one is that we need to combine with checkpoint inhibitors that are either close to market or standard care in that indication. And also that it's likely that this will be the case over the next few years. So we have time to develop the drug in that indication and also that it has relevance when it's ready for market. and one thing that we have not done with ub1 up until now is to combine in trials with chemotherapy several other companies are doing this combining different vaccines with with cpis or and then also in some circumstances chemotherapy and this needs a different study setup because the Chemotherapy component kills every cell that divides fast. That is what we are trying to have the immune system to do, to make multiple copies of itself. It's not impossible to do that, but we will follow the market. Right now, we are developing the vaccine without chemotherapy. And so we will see in the future, we have no plans doing this right now.

Thanks Jens. Then I think we have one last question. I see that you will need to wait some time to get results from the trials that are statistically strong and significant. How do you see the trade-off between this waiting time and if one potentially works as we hope and expect, How to bring as many cancer patients as possible, as early as possible? How do you see this trade-off?

This is not different from any other biotech. Of course, we have been publicly saying that we look at each indication. per se. So, you know, with, as I mentioned, with NIPO positive data, then we will be discussing with the authorities, you know, possibility of an orphan drug designation, breakthrough designation, potential accelerator approval, discuss the next steps of development, and and use that, of course, as supportive data for the other indications. But then we need to look at then, you know, initial and then focus. So it's not that far away, but our approach is that each indication has a value per C and each positive data strengthens the profile. If we want as a as a treatment that can be used in multiple cancer types and in combination with different with different treatments. So, you know, there is always going to be a trade-off between when the data is available and the initiatives. But what I can tell everybody is that we are not going to be waiting for the results on the three studies before we initiate activities. So, as I mentioned, NIPO positive, we have a series already of initiatives planned and activities. that will be implemented and the same thing will happen for each trial as we get to data. So we are going to be moving in terms of meeting with the authorities, talking with potential partners. As soon as we have data, there are a series of initiatives that are triggered immediately. Thank you, Carlos and Ernst, and there are no more questions. OK, so if there are no more questions, I want to thank again everybody. for taking the time to listen to us, and of course for the many questions, very important and interesting questions. session, help to clarify some of the questions you may have. And of course, as usual, we will continue to be keeping you updated on our developments. And we want to thank you for all your support. And please, if you have the opportunity, join us for the ones that are close to Trondheim. And when we have new events at other cities, we look forward to meet with you in person and to in a more relaxed atmosphere to discuss what we do and the value for patients because that's ultimately what we want as a team to make a difference in the lives of cancer patients and provide them with new treatment alternatives. So thanks everybody for contributing also for that effort.