Good afternoon, everybody. Good morning for the ones that are on the U.S. time. Thank you for participating and attending our Q3 of 2023 presentation. This is a very exciting quarter for us, as you will see during the presentation. Again, I will make a short introduction. Our Chief Medical Officer, Jens Bjørheim, will cover the clinical data and the exciting results we had recently. Hans Vassgård Eid, our CFO, will talk about the numbers, and then I will conclude. So please take the opportunity, if you have any questions while we go through the slides, to send it to us, and I will try to address and answer as many questions as possible during the Q&A session. So with this, let's move to the next slide.
You know, I need to show you this, as we are a public listed company. But let's move to the next slide, because as I mentioned, this is not only a very exciting quarter in terms of results, but a very important and remarkable milestone for UV1 as a product, for Ultimovacs as a company, but also for cancer patients. And this is because we started to get the first clinical results from one of our five phase II studies that are running at the moment. We really received very promising results from the first randomized study, the NIPU study, in second-line patients with malignant mesothelioma.
The data showed a very encouraging and clinically meaningful improvement in overall survival when adding UV1 on top of ipilimumab and nivolumab versus ipilimumab and nivolumab alone, and this combination is now two of the most effective immunotherapies available in different cancer types. So very remarkable results, as you will see when Jens cover the data, because this was done in a very, very difficult-to-treat cancer to treat and very advanced patients. And for us, is remarkable and is a key milestone for the treatment of cancer, because this data is the first off-the-shelf universal cancer vaccine that is showing efficacy in a randomized trial. You know, and we are talking about worldwide. The only other cancer vaccine is the Moderna individualized vaccine that also showed.
So now, Ultimovacs is there, a small, biotech company in Norway, really together with Moderna, showing that cancer vaccine really have room to participate in the armamentarium to treat cancer. And what the other part that is very you know, important for physicians, for patients, is the fact that, UV1 has a very competitive profile when you look at the alternatives in cancer vaccines. The reason why is because, as you know, UV1 is easy to administer, just as intradermal injections. It's easy to manufacture. As a matter of fact, we already have UV1 being manufactured under commercial process. Can be sitting in the normal fridge, ready to be administered when needed.
All of these characteristics of UV1 make it really a very competitive profile, and UV1 is well-positioned in the emerging cancer vaccine landscape that now Ultimovacs with UV1 is really opening the door to a lot of other, we hope, a lot of other cancer vaccines coming into the field and really providing as many treatment alternatives for cancer patients as possible. Also, we continue to be very encouraged with the sustained long-term survival data that we are obtaining from our phase I study, the 103 study in malignant melanoma. As you know, this study, we combine UV1 with pembrolizumab. That's one of the lead checkpoint inhibitors. We have reported that between the three-year follow-up period and the four-year follow-up period, there's no confirmed deaths in the patients in the cohort one.
So it's although it's a small sample size, it's very, very rewarding to see that basically what we saw as patients that respond and maintain this long-term survival. That is, as you know, one of the most important aspects that we want to impact, is that patients continue to live for as long as possible. The other news is that, you know, we are really close to getting data from two of our additional phase II studies: the INITIUM study in malignant melanoma and a FOCUS study in head and neck cancer. The patients in the UV1 phase II trial, INITIUM in, with unresectable or metastatic malignant melanoma, are taking longer than anticipated to experience disease progression or death.
You know, we, as you know, we are expecting this data to come in the first half of 2023, then the second half of 2023, then the first half of 2024. And what we have observed is that basically, you know, that we were not getting endpoints showing up. The patients are getting to this flat line. So we really looked, discussed with the advisors, both on the from a statistic perspective, from KOLs and then, of course, with the authorities, and we amended the protocol to be able to report the top-line results in the first part of 2024. We will start analyzing the data in mid-January, and then we'll report the top-line results in the March/April timeline.
So this is very important because you know, like this, we are sure that we are gonna get the data. It's already quite exciting to have this extended non-events in the INITIUM study. And I want to emphasize that the data is gonna be much more mature than when we initially expected to have the results from INITIUM. So it will be approximately 12 months more of follow-up than what we initially expecting. So, in addition, as I mentioned, you know, we will have later in 2024, in the second half, the results from the FOCUS trial in head and neck cancer, while we combine with pembrolizumab.
So again, a very remarkable quarter for us, a very key milestone with the first data on, with a cancer vaccine in a, in a randomized comparative trial, really positioning UV1 and Ultimovacs at the forefront of the cancer vaccine alternatives for treating patients. So if we move to the next slide, we continue to, you know, have tick marks there. You know, it's a, a very excitement, time ahead. As you know, we have an extended extensive, phase II program. When concluded, we will have more than 670 patients enrolled. You know, we have two, collaborations with two big pharmas, where they supply the products for the, for the clinical trials, the, the NIPU study and the DOVACC trial.
So a lot of things happening in the company, and we will also, as you know, we have a platform technology that is now in phase I studies, the TET platform, and we will also be providing additional updates on this, the results of this study now in the Q4 of 2023. So with this introduction, I will give then the word to Jens, so he can take us through some of the data and updates on the recruitment on the ongoing studies. Jens?
Thank you, Carlos, and good afternoon and good morning. In the clinical update today, it will be a few slides on the background for the vaccine. I am putting things into context, how are we moving with our clinical development plan, and then report on the different clinical trials where there are new information available. So if we first move to the next slide here, yes. So as we have discussed earlier, I would like to repeat some of the things around the vaccine we are developing. So, the UV1 vaccine is a vaccine, it's a peptide vaccine, and the antigen for that vaccine is telomerase. We have repeatedly said that this is a antigen that is present in 85%-90% of cancer, and that it is present throughout the course of the cancer.
Just to reflect on that, so telomerase is one of the hallmarks of cancer, meaning that these are features with cancers that you expect to see in different cancer indications. One of the most important feature a cancer need to have is a strategy for eternal cell division. This is something that needs to be in place prior to the development of cancer. So very early on in the cancer development, the cancer cells need to have a mechanism for eternal cell division. In 85%-90% of all cancer indications, the telomerase enzyme is turned on to be, to make the cells available to be in such a position. And this is very important because then, the neoantigen or the antigen is actually a prerequisite.
It's a reason why the normal cells can develop into cancer cells, and it needs to stay on throughout the course of the cancer development. If it's turned off, the tumor cells cannot divide, and the cancer will die. This is in contrast to neoantigens and several other antigens, which are a consequence of the cancer. Mutations that occur in oncogenes, et cetera, are mutations that occur as a development of the cancer. The telomerase, as such, is different, as it is a prerequisite for the normal cells to turn into a cancer cell. Moving on to the next slide. So we have a strategy to try to develop the vaccine in different indications. The reason why? Several.
One, telomerase is expressed in several different indications, so we know that the target is there in the different indications from early on and throughout the course of the cancer. Two, we try to go out as wide as possible because the cancer vaccine itself contains several epitopes that make it available for a large group of patients. There's a link between sequences in the vaccine and different HLA molecules that needs to be in place, and we have shown that the vaccine can be used without any pre-screening for HLA molecules. So then, when we identify an indication where telomerase is highly expressed, we want to understand if there are checkpoint inhibitors available in that indication. For the melanoma patients, there are different checkpoint inhibitors you can choose from, we have selected combined with ipilimumab and nivolumab.
This is one of the standard of care in melanoma patients that have been there over the last few years, and we expect it to be there also over the next years. For the Initium trial, for, sorry, for the NIPU trial in mesothelioma, as we reported at the ESMO conference, we also combined with Ipi/Nivo. The decision to do that was based on some earlier phase I trials, the INITIATE and MAPS-2 trial, that gave signals that Ipi/Nivo could have an effect in mesothelioma patients. For the FOCUS trial, we combined with pembrolizumab, which is a standard of care for patients with this indication that express PD-L1.
The DOVACC trial with durvalumab and olaparib is not a standard of care treatment as of today, but durvalumab and olaparib have shown signals of improved efficacy for patients that are included in the DOVACC trial. The LUNGVAC trial, we combined with cemiplimab, which is a standard of care in non-small cell lung cancer, with the vaccine on top in the interventional arm. All these trials, these trials are phase II trials. What does that mean? That means that this is the trial in between phase I, where you look at the safety and early understanding of dosing, et cetera, and the later phase III trial, where you test the drugs in a larger proportion of patients. There are two things that we will need to consider when you do the phase II trials in a randomized setting.
First, you need to decide what is the difference between the control arm and the intervention arm. To do that, you can read all literature, you can try to understand the signals you have seen with your compound earlier on, and then decide on a hazard ratio. In our trial, trials, we have decided to have a hazard ratio around 0.6. That is what we expect to see as a difference between the two arms in the trial when it's read out. Thereafter, it's important to discuss and agree, how certain would you like to be about your answers?
In a typical phase II trial, the alpha is usually 0.1, and the power 80%, meaning that a positive result is 80% sure, and it's also 20% chance that a negative result didn't capture a true biology for the UV1 vaccine in our case. This is the industry standard for statistics in these kind of trials, and upon a positive trial, that should trigger further development in that indication. So when we decide on the statistics prior to the start of the trials, the statistics should be strong enough, so that if you have a positive trial, that is the signal you need to move on with further development. As we will see, for the most important endpoint, we had a positive trial in mesothelioma.
So from the medical point of view, this is a trial and result that needs to be followed up further in phase III trials. Moving on to the next slide. Few words about the NIPU trial then. So this is in patients with second-line malignant pleural mesothelioma. The mesothelioma patients, they have cancer that is lining the lungs and inner wall of the thorax. It's a tumor type that is almost two-dimensional. It's follow the lining of the lungs, and it's covering the surface of the lungs, so it's also bending. And this trial is an investigator-initiated trial, led by Oslo University Hospital, and they collaborate with Bristol Myers Squibb and ourselves to provide drugs to the study.
A total of 118 patients were included in this trial from June 2020 to February this year in Scandinavia, Australia, and Spain, at highly recognized hospitals treating mesothelioma patients. We had a presentation of the results at the ESMO Conference, now in Madrid, a few weeks back. Also back in June, we sent the data that was available at that point to the FDA, and we were granted orphan drug designation a few weeks back, also in October this year. The trial itself has UV1 and- No, nivolumab and ipilimumab in both arms, and then UV1 vaccination on top in the intervention arm.
Also, just a technical small thing: so the two arms are, in a way, not identical, because in the experimental arm, the patients are vaccinated with UV1 for up to 10 days prior to the first dose of nivo/ipi. So there is a skewing of the start of the CPIs in this trial. Primary endpoint, PFS and secondary endpoints, overall survival, response rate, duration of response, and safety. All of these endpoints were predefined in the protocol, and we will see the results later. To put this study into context, we need to look at the standard treatment for these patients. On this next slide, you can see in the table to the right, what is the current treatment options for these patients. Chemotherapy has been around for the last 20 years as a combination therapy and gives the patients a median overall survival of 14 months.
Different attempts have been tried to improve the prognosis for these patients, but unfortunately, most of the patients are diagnosed with advanced disease. Further, surgery has been tried by different institutions. Even if a patient can be operated, it's not always beneficial for the patient for the total prognosis. So most patients with mesothelioma will only receive medical treatment. Three years back, Ipi/Nivo was approved as a first-line treatment in these indications. It went head-to-head with the standard chemotherapy and showed a median overall survival of 18 months. So right now, there's like two pillars of medical treatment in this indication: the chemotherapy arm, which has been there for two decades, and the CPI arm that was established a couple of years back with only CPIs. There is also a third arm developing, where companies are combining chemotherapy with CPI.
The outcome of these trials also seem promising. The first one reported at ASCO last summer, with pembrolizumab on top of chemotherapy, showed somewhat improved overall survival versus chemotherapy alone. When we started the NIPU trial together with Oslo University Hospital, the CPIs were not approved as a standard of care in mesothelioma patients, and due to that, it was not possible to do the trial in a first-line setting, so the NIPU trial is in second line. Now, where Ipi and Nivo is approved as a first-line treatment, it's natural to move the treatment with UV1 up in the first line. Moving on to the next slide, we can look at the demographics in this study. So totally 118 patients, equal number of patients in both groups.
Males are over-represented in the study due to different work in industry and construction, et cetera, with materials containing asbestos. Around 70 years old is the age of the diagnosis. This is a disease that have a very long latency period, 10-50 years. Most patients were ECOG status 1, meaning that they can do daily activities, but with some effort, it is not effortless. Histology, as expected, most patients with epithelioid histology between 75%-80% in this trial. For PD-L1 status, this is interesting because in earlier trials, it has been shown that if you have a low PD-L1 expression, it's linked to poorer prognosis for patients. It was expected to have around 30% with the PD-L1 negative patients. We see around half of the patients without PD-L1 expression.
Unfortunately, one-third of the patient samples are not available at the current time point. Moving on to the next slide. So regarding the safety, so the Ipi Nivo combination is quite toxic combination. Over the last years, the doctors have learned to handle their safety better than in the early days. So they have treatments now that can, in a way, stop the development of the safety events before it gets too dangerous. Nevertheless, there's a lot of serious adverse events with this combination. Adding UV1 on top doesn't lead to further increase in this percentage. As you can see from this slide, in both arms, there's around 60% of serious adverse events. This is happy news moving forward.
It's very important that the safety of new drugs don't interfere and destroy the current standard of care, so they have to stop treating with standard care due to the new drug. Moving on to the next slide. The first efficacy results from this trial. So, to the left, you can see the response rate as read by BICR, meaning central assessment of the images. And what was seen was a doubling of the response rate in the UV1 arm versus the control arm, 16%-31%. Further, for overall survival, the hazard ratio in this study for risk reduction of death was positive. It was seen a risk reduction of 27%, which was within the threshold for the statistics in this study. This is defined in the box below the Kaplan-Meier curve.
Kaplan-Meier curves are a different way of looking at the overall survival, for example, and it's important to understand what is the observation time for the curves you are observing. At this point, the observation time in this trial is 17.3 months, indicated with the vertical red line on this image. And if you ask statisticians, you can say that everything that is to the left of the red line is more or less what is more or less what it will be when you have more mature data. As for the part to the right of the red vertical line is still immature and need further observation before you can draw any conclusions.
We read this graph as the curves are starting to separate at six months, and we see a continuous separation of the curves until the vertical line indicating the median observation time. We are really eager to follow this overall survival further to see if the split between the curves continues or how it develops into the future. But the conclusion from the overall survival assessment is that there's a 27% reduction in risk of death at 17.3 months, and that is also statistically significant. And one last thing to mention here is that the median observation time is quite long, 17 months, as I said, as compared to the median observation overall survival that you see in second-line patients.
Meaning that, around 12 months, meaning that the median observation time in our study at this point is longer than the median overall survival seen in second-line patients. Moving on to the next slide. As was presented back in June and also presented at ESMO with the Kaplan-Meier and the numbers are the progression-free survival. So, PFS, central review was not positive. That was the primary endpoint of this study. It was also predefined to do a statistical analysis based on local assessment of the images. In this analysis, the difference were highly different, hazard ratio of 0.6. The difference between these two readings of the same images will hopefully be further discussed into the future.
For us, in Ultimovacs, we observed this difference, but it's not of high importance for us moving forward. The one important endpoint that will, in a way, guide us into further development is overall survival, and based on the predefined statistics, we met that endpoint in the mesothelioma trial. Moving on to the next slide. What is the next step then for mesothelioma development? So, starting a clinical trial with patients, with all the ethics and resources needed, the financing, time consumption, et cetera, you, in a way, make a contract with yourself. So when a clinical trial is designed, you need to have a purpose with the trial. You need to decide upfront what you expect to find and what you want to do if you meet those expectations.
In the mesothelioma trial, it was predefined statistics, and we have met that with the overall survival and the response rate in the study. We are very happy about this and have already sent the early results to the authorities and received back orphan drug status for this trial. We are also currently in discussions with the authorities to see how the way forward with the authorities will be. Further, it's important that also the results are discussed with third-party experts in the field that were not included in the study, but to understand their response to the data and also the way forward with this trial. This is very important in designing a phase III trial with UV1 in this indication.
Moving on to the next slide, and, the next trigger that comes up now, the INITIUM trial, which is our sponsor trial. So we have done two phase I trials earlier, one UV1 IPI trial in 12 patients and one with UV1 pembrolizumab in 30 patients. All patients are unresectable Stage III or metastatic patients, and also in this study. Enrollment in this study started in June 2020, enrolled patients from 39 sites in U.S., U.K., Belgium and Norway, and last patient enrolled in July 2022. This is an endpoint-driven study, with where we have been waiting for 70 endpoints to occur, with PFS as primary endpoint. The statistics in this trial is the same as in the NIPU trial, with a one-sided alpha of 0.1, hazard and power of 80.
Also, in parallel with the INITIUM trial, we decided to also have a supplementary single-arm study, where we take more biopsies from the patients. All patients in this study receive UV1 plus IPI and Nivo. 21 patients are enrolled in this study, so it's fully recruited. Results will provide in-depth data on biological activity and mode of action from the vaccine induced T-cells. This will be very important for us moving forward into phase III and also in our discussions with the authorities regarding the UV1 vaccine. Moving on to the next slide. So we have earlier reported, or years back, reported that we expected a readout of the INITIUM trial first half of 2023. In April, we reported that we had not met the primary endpoint in this trial, and the same happened in August.
We also informed at that time point that we would discuss with our third-party statistician and with the authorities, etc., to understand the way forward for a readout of this trial. Carlos mentioned that in that in his introduction, that the data here is very mature. What we actually see in this study is very little. Over the last years, very little has happened within for recruiting new events in this study, and this is really happy news for the patients. Also, we expect that most of the patients are true and down on the line on the horizontal line in the diagram. So. And that means that little is happening with these patients when it comes to efficacy from the drugs.
Based on that, we have amended the protocol so that we will have a readout of this trial with less than 17 points. This will happen when all patients have been in the study for 18 months, and this also means median follow-up time of approximately 24 months in this study. There will be then the cutoff in January, and then a readout of the data in March, April, first half of next year. Moving on to the next slide. We also have a third trial that is fully recruited, the FOCUS trial. This is a trial in patients with head and neck cancer that express PD-L1. In this indication, pembrolizumab is a standard of care. This is a German trial initiated by Halle University Hospital outside of Berlin. Seventy-five patients are enrolled in this trial.
The last enrolled patients in August 2023. All sites are in Germany. FOCUS, it has a somewhat different design than the other four phase II trials, as this is a landmark trial. It meaning that you are reading the endpoint at a specific time where all the-when all the patients have been through a specific time point, and you read that time point. We also would like to put the primary endpoint of PFS together with the other endpoints, so we wait 12 months after the last patient were included in this study to have a readout of all the endpoints in this trial. This is expected in August 2024, since the last patient was included in August 2023, and we expect a readout of this trial second half of 2024. Moving on to the next slide, and then the two last phase II trials.
So to the left, the DOVACC trial in ovarian cancer patients. So these are women with a BRCA-negative cancer, and they have received a second round of chemotherapy, and if they respond to that second round with a partial or complete response, they can be randomized into this trial. Three arms, olaparib in all arms, durvalumab in the middle arm there, and durvalumab and UV1 in the third arm. The statistics in the trial is between arm A, olaparib, and the triple combination arm. 184 patients are expected to be enrolled in this study, and first patient were enrolled in December 2021. As of now, 46 patients are enrolled in this trial. Over the last months, large sites and large countries have opened for screening of patients in this study.
Just to put it in context, so when the patient is on chemotherapy, they are selected as a screening candidate for this study. They need to go through different testing, for example, an HRD test, and then they continue with their chemotherapy until that is finished, and that can take some months. Over the last months, we have seen that the number of screened subjects or screening that are in screening in this study has increased a lot. The enrollment since last update is not increasing, it's rather stable, but we do see that the number of patients that are in screening is far higher now than it has been earlier. This is important for accelerated inclusion of patients moving forward.
For the LUNGVAC trial, the Norwegian trial in non-small cell lung cancer, where we combine with cemiplimab. So it's cemiplimab plus minus the vaccine on top. This is first line patients that have no EGFR or other targetable mutations at diagnosis. 138 patients from 8-10 hospitals in Norway will be included. Recruitment right now, around 10% of the patients, or 13 patients, enrolled in this trial. We are currently discussing with the investigators about the way forward. It's somewhat lower inclusion than expected in this trial, and we are looking into different opportunities moving forward with this trial. For both these trials, we will have an update of the expected readout at the quarter four reporting in February 2024.
Moving on to the next slide. We also have this happy news about the overall survival in the UV1-103 study, so that is the trial where we combined pembrolizumab and UV1 in patients with unresectable or metastatic malignant melanoma. We have followed these patients for quite a while now, and we saw now from the first cohort of patients, it was two cohorts in this study, one with 20 patients with a lower dose of the adjuvant GM-CSF, and 10 patients with the normal or, you know, used dose of GM-CSF that started later. For cohort one, after 48 months of observation, we see a survival rate of 73.8%.I f you look at the Kaplan-Meier curve to the right, you can see that after around 18 months, this curve is really starting to flatten out.
This is something that is very important for these patients, and we will continue to follow these patients over the next years. Moving on to the next slide, the TENDU phase I trial. So this is the first clinical trial evaluating the TET technology. So this is a trial investigating a prostate cancer-specific vaccine, with antigens other than telomerase, so they are prostate cancer specific. It's a dose trial with three different dose levels. All patients have been included. The endpoints in this trial is safety foremost. That is the most important thing, understanding what kind of dose to move on with, in further development and also immune activation.
To do all these things and to follow the patients for a relevant period of time, there has been some time since the last patient were included, but we expect now, the study results to be reported in Q4 this year. To date, we have not seen any safety concerns within this trial. Moving on, I guess this is for Hans now, so I'm leaving the word for you, Hans.
Thank you, Jens. And then we're moving on to a brief financial update. So on the next slide, we will have the key highlights. By the end of the Q3, we had a total cash holding of NOK 300 million or approximately $27 million. And this gives an expected financial runway to the second half of 2024 through the top-line readouts in the INITIUM trial and the FOCUS trial. And this guidance is consistent with the guidance we have been given, been giving earlier. Looking at the operating results, the EBIT for the Q3 and on, we had a total EBIT of NOK -55 million.
For the year to date, after Q3, we had a total EBIT of NOK -156 million, and the profit before tax was quite similar for the Q3, NOK -56 million, and year to date, NOK -133 million. Looking at the OpEx, the two main cost drivers or cost components are payroll expenses and R&D expenses. And regarding payroll expenses, we see that the underlying salary expenses, they are fairly stable, but with some quarterly variations in total personnel expenses due to the share price-driven allowances related to the share option program. Regarding R&D and IPR expenses, we see a higher level this year than the previous year, driven by clinical trial activities and manufacturing or so-called CMC activities.
Having said that, the level in the Q3 this year is clearly lower than the Q2 this year, which in a good way illustrates that we have these significant quarterly variations in R&D costs that we have talked about on several occasions earlier. Looking ahead, the operating expense levels should be expected to continue at a fairly high level, again, with quarterly variations, driven by further progress of the phase II trials, CMC development and other R&D activities. So looking at the financial guidance we give for financial runway, implicit in that is that we should expect the average operating cost level for the next quarters to be slightly higher than we saw this quarter, and again, with these variations from quarter to quarter.
Moving on to the next slide and going a little bit more into detail. The total OpEx for the Q3 amounted to NOK 55 million, up from NOK 44 million last year, and the total OpEx year to date after the Q3 was NOK 156 million, up from NOK 111 million last year. Let's look at the main cost elements behind this. The total payroll expenses were higher in the Q3 and also year to date compared to the same periods the previous year. Their regular salary costs were higher due to one more employee, one more FTE in 2023. And, of course, we also have a, had a regular salary adjustment as of January, which also influenced the cost level.
The share option expenses, they fluctuate with the company share price, and these explain most of the difference in total payroll costs between the quarters and year-to-date periods compared to last year. Then, regarding the external R&D and IPR expenses, the R&D costs were slightly higher in the Q3 and significantly higher year to date compared to the same periods in 2022. The main contributors to this, to the increase, was the INITIUM and the NIPU clinical trials and manufacturing or CMC activities. When it comes to the third main cost element, other OpEx, we saw a slight decrease from the previous year. On the next slide, we have specified the operating cash flow, which deviates somewhat from the operating expense level.
And on the next slide, we have the quarterly breakdown of the cost, which may maybe possibly give the best overview of the development in the specific cost elements over time for those wanting to dig into that. Then we will move on, and I'll give the word back to Carlos for the last section.
Thanks, Hans. Thank you, Jens. So if we move to the next slide, again, you know, very rewarding to see that basically we have been delivering on the, on the, getting the data, getting important data. Again, for this year, the only, the only box that we need to tick is, as we promised, when we will give an update on the readout of the TENDU study. And then I believe we have had a very successful year, and again, also the, a, a very exciting period coming up with the INITIUM data expected to, you know, earlier in the, in the new year, and then with the FOCUS trial coming afterwards.
And of course, we will continue to provide updates on the overall survival follow-ups with the 103 study in the melanoma in combination with pembrolizumab. So, you know, if we move to the next slide, I think that, as I mentioned, a very, very important quarter for Ultimovacs UV1 and cancer patients. We are being the first cancer vaccine to deliver randomized data showing there is a benefit of adding UV1 on top of the standard of care immunotherapies. You know, this is very important because, as I mentioned, a lot of other companies that are operating this space, you know, are have been waiting for this data, because we are the first ones showing that the concept of a universal vaccine has really the data supporting in it and supporting moving forward.
So providing really a very important new tool in the treatment of cancer patients. As we know, malignant mesothelioma is a very hard-to-treat cancer, so in a way, these results that we achieved, very, very impressive, exceeded the expectations that we had in the beginning. As Jens mentioned, of course, we already started acting on these results. We are discussing with the regulatory authorities, with key opinion leaders, and, you know, debating and discussing with them what will be the path, the path forward for UV1 in mesothelioma. As you know, INITIUM, our main study, our lead indication, is now finally, you know, starting to analyze the data mid-January, and this will give us, you know, results that we are all expecting and hoping for positive ones in the March, April timeframe.
But, you know, we don't stop there. We will get then the results of FOCUS in a very, also very, difficult cancer to treat. And, you know, the slower than initially expected, but we continue to recruit patients in DOVACC and LUNGVAC, and we will provide an update with the Q4 2023 report. We are now ready to share with you soon the results from the TENDU study. And as you can imagine, and we have told you, you know, on the basis of the NIPU data and the updates on INITIUM, we are intensifying our business development activities and sharing all this recent data with potential partners. We continue to be very disciplined, you know, with the cash that we have, and really, making most of the investments in the clinical program.
And, you know, with this, we extend the runway through the second half of 2024. Very importantly, taking us through the readouts of the next two studies, the INITIUM and the FOCUS study. And with this, I want to thank you for your time, your attention, your support of Ultimovacs, and we will now move to the Q&A session. Thank you.
Thank you, Carlos. We have received a few questions, and the first one is regarding further data from the NIPU trial. There are actually two questions we can take together. One, a specific question, and one general. The specific one, and this, I guess, is for Jens: On the NIPU study, have you stratified the overall survival data based on PD-L1 expression? And I'll take the general one at the same time. When do you expect an update with more mature data from the NIPU study?
So, regarding the first question, so it will be looked into different subgroups of patients and associated with different outcomes, and that efficacy endpoint outcomes. This is something that will be discussed in the publications, publication from the authors, and I know they are already now working with such a publication. It's also natural that they will update the efficacy endpoints, overall survival in such a publication, so it's as up to date as possible. As far as I know, it's not decided at this point where and when overall survival data will be updated. But this is data that will be followed closely and presented at relevant conferences and also in this publication.
Thank you, Jens. I'd also like to mention that we have received a couple of questions regarding the involvement in LUNGVAC. I think that was properly addressed by Jens, and this is, of course, a topic that we will come back to in the next quarter report, looking at the different alternatives to improve involvement in that trial. A specific question to Jens, related to the 103 trial. When you reported the survival data for the cohort one after four years, you reported that one of the patients could not be reached, one of the 17 patients. Have you managed to find out the current status of this patient?
So, we do not have further information on this right now. Then the Kaplan-Meier and the information on these patients will be updated when we have new information available. But, we are actively following up with all patients and the CRO that is following these patients in all our trials. So, so that the best possible data can be provided over time for the different studies.
Yeah. I see that we are running a bit short on time, so- And we have few questions left, and so I think this will be the last question, probably to be replied by Carlos. "Merck and Moderna's progress to date for their personalized mRNA vaccine, together with the checkpoint inhibitor Keytruda, has been positive. Could you provide some details on how UV1 could offer differentiation from the mRNA approach from Merck and Moderna?
Oh, absolutely, and again, a very good question, and of course, a topic that we follow closely. I think we need to differentiate first, you know, where the Moderna study has been running. These are as adjuvant therapy. These are in patients, melanoma patients, that had a lesion that could be removed surgically, and then they were followed by treatment, what is called adjuvant treatment. So these are patients that are not as sick as, for instance, the patients in the INITIUM study. You know, they are also an individualized vaccine, as you know, very complex to manufacture, to administer. You know, UV1 as having data showing that we have efficacy now with the NIPU study in much more advanced patients, we can be used across the board in multiple cancer types.
But what we see really is that there's no competition between the Moderna approach and the UV1 approach. We, you know, don't look at them as competitors. We look at them as complementary, not... You know, they are not gonna be used as broadly as we expect UV1 to be used, but there will be patients that will benefit from their approach and more patients that will benefit from our approach. As a physician, you know, I always say that the more treatment alternatives patients have, that's what we want. You know, we don't want just the Moderna and then and UV1. We want more treatment alternatives for cancer patients. The more, the better. Very different approaches, very different complexity in terms of how to manufacture the vaccines, the cost, and how to administer, but each of them has a role in treating cancer patients.
Thank you, Carlos. That was the last question for today.
Okay. So thank you, everybody, and again, continue to send us your questions, and we hope to provide you the next update for the TENDU study now in the rest of the year. So thanks, everybody, and have a rest a good day.