Good morning, everybody. I want to welcome you to our Q2 2021 presentation. We are delighted to have you joining us in what was a very exciting and successful quarter. Together with me, my name is Carlos Soze, and I'm the CEO. I have 2 other members of our team.
Jens Biorheim, our Chief Medical Officer, enhance Vascoeur d'Ayd, our Chief Financial Officer. If we move to the next slide. You know, I need to show you this as a publicly listed company, and we can move to the next slide. So, this morning, we will be covering you, with you the highlights of the quarter. Jens will cover the operational update.
Hans will cover the financials and the news flow, and we will finish the presentation with a space for Q and A. So, I suggest you During the presentation, if you have any questions to use the webcast system to send those questions. Good. So let's move to the next slide. As I mentioned, A very successful quarter for Ultimavax, as we have been having for the past year.
Among the highlights, of course, probably the most exciting highlight was the very encouraging and positive results We presented from our Phase 1 clinical trial a VUV1 when combined with pembrolizumab in malignant melanoma. As you probably know, pembrolizumab, KEYTRUDA is, one of the standards of care in the treatment of melanoma. In this study, we have a total of 30 patients that are split in 2 cohorts. The data from the 1st cohort of 20 patients were presented in June at ASCO Annual Meeting. And as we mentioned at the time, ASCO is the biggest cancer medical conference in the world that normally, it puts together 45,000 specialists in Chicago.
Of course, Due to the pandemic, this year was a virtual conference, but, we were very proud to have our data except to be presented at this very important conference. Last week, we were also very excited to share with you the results from the 2nd cohort of TED patients. Basically, you know, when put together, the results from these 2 cohorts show a consistent set of data With very strong initial signals of clinical response and a good safety profile, really supporting the use of UV1 in combination treatments. Jens will give you more details on the study, But I want to highlight here, a factor that normally people don't pay much attention. That is the safety profile.
These patients are in poor health, are receiving several medications. And it's extremely important when you use combination treatments that, you know, you don't bring additional safety concerns and side effects to the treatment. And that's one of the key adventures of VV1 and really highlighting the importance in addition to the efficacy of this very good safety profile. When we move to the next slide. We continue progressing with our Phase 2 program, as you know, a very ambitious plan with more than 500 patients to be enrolled.
Our LEAD program, the initial trial with 154 patients, It's, where we combine with 2 of them, standards of care also in the melanoma, nivolumab and ipilimumab. Despite the challenges of the global pandemic, we continue to enroll patients and this was a very good quarter for us. So we have now enrolled as of yesterday, 68 patients versus the 40 patients that communicated to you in the previous report. The NIIPIL trial is an investigator initiated study in mesothelioma. This The study is sponsored by the Oslo University Hospital.
And here we supply UV1, and we also have a collaboration, Bristol Myers Squibb, where they supply ipilimumab and nifolumab. We have now, as of yesterday, 38 patients enrolled compared to the 29 of the last quarterly report. The DUVAX trial is another one of our big Phase 2 trials. This is again a collaboration study that, the sponsor is the Nordic Society of Gynecological Oncology. That is part of a big European umbrella, the most important organization to run clinical trials in gynecology cancer.
And we collaborate with them supplying and AstraZeneca supplies their products And this indication is ovarian cancer, a very important indication with high unmet medical need. We have received now the regulatory approval of the 1st country, and we expect the 1st patient to be enrolled during the Q3 of this year. Being a European across Europe, a clinical trial, there will be a multitude of countries and centers to be enrolled. We are also very happy that in the FOCUS trial that we collaborate with a highly specialized group, and just outside of Berlin, in Germany, where there will be 10 centers all in Germany enrolling patients, where we are studying head and neck cancer, And we combine with pembrolizumab that is a standard of care in this indication. And as I mentioned, we are very happy that the first patient was enrolled.
So, study progressing, despite all the challenges that we are all familiar with. In the next slide, TENDUM. This is the first study with a product coming out of our second platform, The TET platform. As we communicate to you, we started enrolling patients in February. Each patient needs to be enrolled at a time because this is a Phase 1, particularly primarily for safety.
So now the first three patients in the 1st cohort, have shown no safety concerns. So the Drug Safety Monitoring Board has allowed the study to progress to the next dose that is 400 micrograms. So we also expect during this quarter to enroll start to enroll patients in the 2nd cohort. We all are impacted by the pandemic, the COVID-nineteen, and this has an effect in all of the biotech industry and Also, the general ability to conduct clinical trials. You know, although the situation is progressing in some countries, you know, the new variants Post additional challenges.
So as a company, we continue to monitor the situation and to implement activities to minimize the impact on patient recruitment. We are very proud that despite all these challenges, In the past 12 months, in the middle of the pandemic, we were able to recruit a total of 100 patients in all of our studies. And this is due to the, hard work and dedication of our clinical operations team, our medical team, and of course, all the health Personnel in the hospitals that are collaborating with us. So we are very proud of this number. But of course, We need to continue alert and monitoring the situation and working very closely with these centers.
If we move to the next slide. And now I give the word to Jens to give you a little bit more details about our programs. Jens?
Thank you, Carlos, and good morning to all of you. If you go to the next slide, You will see an overview of our ongoing clinical trials in ULTIMAGS. We have, as of today, 5 active trials. And as you remember, we also have 3 Phase 1 trials that we have conducted earlier that Now are in long time follow-up. They are not presented in this slide.
Also, as you know, and as Carlos stated, Our lead program with, UB-one vaccine is in the malignant melanoma space. We have the Phase I trial that we presented Results from at ASCO in June and also now in August, come back to that. Further, as Carlos stated, We also have the unique trial in malignant melanoma with a different combination, the ipilimumab and nivlimab combination. And then the 3 other trials where we contribute with drug, with different indications and different combinations of drugs, 1 in mesothelioma, 1 in ovarian cancer and 1 in head and neck cancer. And then, Last, we also have this trial coming out of our new platform, the technology, which is the Phase I trial in prostate cancer.
If you go to the next slide. So this is the design of the Phase I trial that we presented at ASCO, the first cohort, you can see to the left that there are 2 different doses of GM CSF in this trial, one with a lower dose, 30 7.5 microgram and 1 with 75 microgram. The first cohort was presented at ASCO and the second one, Top line results from that one was presented now earlier in August. All in all, for both cohorts in this Try. We have seen a very good safety profile.
And by saying that, we mean that it's In the drug, UB-one will not add any, alerting safety to the already existing standard of care. And this is a very important point, as also Carlos stated, in the further development of the vaccine. There is also interesting signals of clinical response in these cohorts. If you go to the next slide. We have here compiled the different efficacy results, response rate, progression free survival and overall survival.
On top, you can see the response rates for the 30 patients in Cohort 12 combined, and we saw a complete response in 9 out of 30 patients. Further, partial response in 8 out of 30 patients, this leading to an objective response rate of 57% and complete response rate of 30%. As you might remember from earlier this summer, we have reported 1 more partial In those presentations, recently, one of the patients were reclassified as The stable disease instead of a partial response. When it comes to the medium progression free survival, As you know, from the cohort 1, we have seen that readout at 18.9 months. For the cohort 2, the median PFS is not reached at 18 months landmark readout.
And when we combine these two cohorts, As we have done in this presentation, the median progression free survival has not reached would not been reached at 12 months. For the overall survival, as you remember from earlier, the cohort 1 after 12 months Report out on 85%, cohort 2 readout at 90%. For those 2 combined, after 12 months, We see a total of 87% survival for cohort 1 plus cohort 2. We also have some more data for cohort 1 after a longer follow-up time. And we see that after 18 months, it was 80% survival in this group.
If you go to the next slide. So as earlier, we have here compared our data with the historical pebrolizumab data. This is also Always something that should be taken with some kind of cautious because it's different studies. It's not a randomized study. So this is just to get an impression of the results as compared to already existing results for the pembrolizumab standard of care alone.
When it comes to the objective response rate, you can see the results to the left with a range of 33% to 37% for pembrolizumab alone. Those results are from the KEYNOTE-six study, which was used for regulatory approval and also a study that has been followed up for several years. Our objective response rate is 57%. If you take out those patients with a complete response rate, you can see the results to the right, 30% in full 1 on 3 study with 30 patients as compared to 5% to 12% in the KEYNOTE-six trial. If you go to the next slide.
In this slide, we present the overall survival and median progression free survival and compare that to the pembrolizumab data from the same study, KEYNOTE-six. To the left, you can see that after 12 months landmark, we had 80 7% overall survival in our study as compared to 72% to 75% in the KEYNOTE Trial for the median progression free survival for pembrolizumab monotherapy, 5.5 to 11.6 months have been reported for that. We have seen, as I have stated also earlier, in Cohort 1, 18.9 months, median PFS, not reached for cohort 2 and Also not reached for cohort 1 plus 2 combined at 12 months. If you go to the next slide. So these results from the 103 trial, they give us a very good safety profile to further work on the development of UB-one And also give us some support in the further development when it comes to the efficacy side.
We have, as you know, already Started a new trial in the malignant melanoma field last June in 2020, the initsum trial, as you can see to the left. In this trial, this is our sponsored trial, and we are very happy that the recruitment and enrollment of Patients has been very good over the last period of time. And to be able to include patients during this Pandemic, it has been very important that we are in a way direct contact with the different hospitals and are supportive together with the CRO that is working with the trial. We have been conducting different presentations and discussions and meetings with all The hospitals in this trial over the last year, and we will also do that in the future to have a close collaboration. It's a bit different from what it was before COVID-nineteen, where you had the possibility to meet Face to face with the investigators, but we think we have proceeded quite nicely also with all the teams meeting with the different hospitals.
The NEPA trial to the right, As you know, this trial is sponsored by Oslo University Hospital in mesothelioma patients. Sites have been opened and the recruitment are going well also in this trial. The group of investigators that are conducting this trial, they have The study design in the publication over the last half year, and this trial has got a lot of attention in the scientific environment where they work with mesothelioma patients. Both these trials, as you know, will read out in the end of 2022, and we look forward to those results. If you go to the next slide, you can see here that new commerce in ULTOMAGS, DUBAK Trial to the left, which is in ovarian cancer patients and the FOCUS trial to the right in head and neck patients.
For the DOBAC trial, as Carlos said, regulatory approval is now in place in the first country, And recruitment in this trial is expected over the next near future. The trial is a very large one. It's the largest trial in Ultomax With 184 patients that will be recruited from more than 40 sites in 10 European countries. Expected top line results from this trial will be in 2023. For the FOCUS trial, that trial has now included the first The patient now in August, the trial is a German trial with 10 sites in Germany and will include 75 patients in a 2 to 1 randomization.
So there's 50 patients in the intervention group with UB-one and pembrolizumab, and 25 patients in the control arm. Both these trials will expected to report results in 2023. For the DUVAC trial, This trial was presented in the Nordic Skin Cancer Meeting in March, And it will also be presented at different meetings over the next half year to also increase attention around this Right. If you go to the next slide. So this is the TENDU Phase I trial coming out of the This trial was started back in February.
It's a Phase 1 trial We have tried to identify the right dose of treatment. And there are 3 different dose levels, and Three patients will be included at each level. The first level of patients have been included this spring, And the safety from those patients, both clinically and lab measurements, has been reviewed by the safety board And found to be okay, so the next cohort will start to include patients. We expect the next patient to be enrolled now in the near future in this trial. Also from this trial, over the next months, it will be possible to have a broader understanding of the safety as such.
And we will report when there is relevant thing to inform the market. The next dose will be, 400 micrograms in this Study as compared to 40 micrograms in the first cohort of patients. I think this is the last slide from the medical part. So I guess we can leave the word now to Hans, taking care of the finance park. Thank you.
Thank you, Jens, and good morning, everyone. We can move to the next slide, Slide 17. So when we look at the key financials For the last quarter, I think there should be no surprises. Starting at the total numbers, the total loss in The Q2 of this year amounted to NOK 36,000,000 and that compares to NOK 35,000,000 Norwegian Kroner has a loss in the same quarter the previous year. If we look at the year to date numbers, First half year 2021 gave a total loss of 70,000,000 compared to a total loss of 65,000,000 first half of 2020.
If we look at the operating expenses, which Should be the most interesting year. We see a similar picture. The operating expenses for the Q2, this year alone amounted to NOK 39,000,000 and that compares to NOK 36,000,000 in the previous year. And if we look at, year to date numbers for the first half of the year, this year we had total operating expenses of SEK 70,000,000 compared to 67,000,000 the previous year. So let's look at, more let's look more closely at the main cost components.
Starting with the payroll expenses, we see, somewhat higher costs, in the last quarter and in the first half year Compared to the same periods in 2020, for the first half year, the total payroll expenses We're at 26,700,000 compared to 33,200,000,000 last year. And that is mainly due to 2 components. We have somewhat higher share option costs this year, and we also have well, and we could mention that most of the share option costs Our non cash costs, but they are booked according to IFRS. In addition, we have 2 more full time employees this year, which also increases the costs slightly. Then if we move to the Now, we are not moving to the next slide yet.
We are moving to the next cost component, external R and D and, IPR expenses. The R and D costs, in the last quarter and also year to date, First half year are approximately at the same level as the same period in 2020. Looking at the year to date number, 36 £600,000 compared to 38,000,000 in 2020. We should then mention that When we receive public grants, we book the public grants as cost reduction items and allocate that out on the main cost components. So, in the R and D numbers here, we had 6,000,000 in grants as a cost reduction booked this year compared to 3,000,000 in the previous year.
So that means that the underlying increase in cost is correspondingly higher. We see that the costs are approximately at the same level as the previous year. Then looking at cash and cash flow. At the end of the second quarter, we had a total cash holding of NOK382,000,000. We have taken some measures to reduce the risk related to the euro exposure We have in our projected R and D costs.
So, we have made 2 specific measures. 1 is that we have converted NOK 50,000,000 into euro held in a bank account. In addition, we have entered into a euro currency future contracts totaling NOK 100,000,000. And so we have a total conversion of exposure from NOK to €150,000,000 The future contract is planned to be swapped on a monthly basis going forward. Yes.
Then we can move to the next slide, slide 18. We also see that negative operating cash flow in the Q2. It's more or less at the same level as we have We do expect A further increase in the negative operating cash flow in the second half of this year as we have also guided earlier. And this is due to the initiation of the 2 new Phase 2 trials, increased Patient recruitment across all 4 Phase 2 trials and also some other R and D costs. We can move to the next slide, slide 19.
This is a quarterly overview of the different cost components Provided as a service to analysts who want to look at, details on a quarterly basis. So we're not spending more time on that. We can move to Slide 20. Looking at the expected news flow going forward, within the malignant melanoma field, we have now described That we have shared, what we perceive to be very promising results in the Phase 1 trial where we combine UB-one with Permolizumab, so we came with the cohort 1 data at ASCO in June. And we also earlier in August Share the cohort 2 data from that trial.
And during, Q4 this year, we expect to share 2 year data from the first cohort in that trial. Then on patient recruitment, We announced earlier this month that we enrolled the 1st patient in the FOCUS trial within head and neck cancer And we now expect also to enroll the 1st patient in Dovak, the ovarian cancer trial, fairly soon and within this quarter, the Q3 of this year. In the Q4, we also expect to share interim safety data from the TENDU trial, which is the first clinical trial coming out of the TET platform. And then, as, of course, very important news flow events, we Expect the readout of the, all the 4 Phase 2 trials towards the end of 2022 for, Inisham and IPU and in 2023 for TOAC and FOCUS. And with with that, I will give the back word back to Carlos to summarize.
Thanks.
Thank you, Jens and Hans. So to, basically to summarize and before we move to the Q and A, I think the key takeaways from a very successful quarter, as I mentioned, are the very encouraging and positive results from the phase 1 Clinical trial, combined with pembrolizumab in malignant melanoma and the broad UV1 Phase 2 program is progressing well, despite all the challenges. We have now 4 indications in different combinations. So, a very broad program that We'll enroll more than 500 patients at more than 90 hospitals in approximately 15 countries. So you can see this is a very ambitious, problem requiring a lot of dedication from a team in a small company, and we are very proud of that.
We are also very happy that the development of the TET platform continue. And this is particularly with the TENDU study that will start to give us initial safety information about the product and the platform and also in terms of immune activation. So, we are, as I mentioned, moving now to the to the 2nd cohort. And we expect to have additional information as Hans mentioned towards the end of the year. So again, a big, A big thank you to a very dedicated team that has been very committed to delivering on all these results.
And, of course, also the support from our board and our shareholders. And with this Key takeaways, I will move now to the Q and A section. And please, if you haven't already, send us your questions. Thank you all. So Jens and Hans?
Yes, we have received several questions. So we'll start with one related to GM CSF in the trial we have reported. The question is What conclusions do you draw from the Phase 1 trial in melanoma you recently reported cohort from cohort 2 from related to the use of different So, this is of GM CSF.
Jens?
Thank you for the question. So, in total, there is 30 patients in this, 103 trial, 20 with the lower dose of GM CSF and 10 patients with a higher dose of GM CSF. When it comes to both the safety part and efficacy part, We do not see any numerical differences. The trial is, of course, too small to have any statistical evaluation of the results. Also, the reason why we have 2 different doses of GM CSF is also for Administrative reasons when we are working in the file going forward.
As you know, in all our trials, As for our, Initium and NIIPU starting in June last year, we already decided at that point to move further with a Higher dose of GM CSF. So 75 micrograms will be the dose moving forward. And on top of that, we do not see too much we don't see any difference between the low and high dose when it comes to safety and efficacy.
Yeah. And there is another question that you probably have answered a large extent, but I'll read it anyway. Given the safety data you now have with different doses of adjuvant, are you happy with Strategy to use the 75 microgram dose?
Yes. So, for different peptides Over the last decades, different doses of GM CSF has been used from doses that are lower than our lowest And to higher doses than the highest dose we use. The most important thing with the GM CSF is that The drug attract these dendritic cells, the antigen presenting cells, to a specific area in the skin. And then we inject the peptides in the exact same spot. We do not have any proof of that, but it's likely that there's no, In a way, those relationship here, it's more like the digital thing that either there is a GM CSF Present there to attract and activate the cells or not.
So we are very, very happy with the dose of 75 micrograms. But, the ultimate Answer to these questions will be when the Phase II trials read out. But we are happy with the signals we are seeing now in this VALOR 3 trial.
Okay. Then another question from the Phase 1 trial in melanoma. Could you please clarify the ORR reclassification? If I remember correctly, There was one partial responder that was reclassified as a complete responder in cohort 1 after the ESCO abstract had already been submitted. But is there now another separate reclassification of a partial responder into a stable disease?
Was this in Cohort 1 or 2?
Thank you. Thank you. So, both the reclassifications are within cohort 1. There were one that moved from a partial response to a complete response, early from early spring, this year to the ASCO presentation. A different patient from that is reclassified now from partial response to a stable disease.
Just a few sentences on that patient. So there is a patient that was included in cohort 1 with 2 target lesions. That means that is the 2 lesions they take picture of and follow through the treatment. During the spring, these two lesions turned out to give a partial response in this patient. At one point, this patient decided to leave the study for further follow-up.
So there is no new pictures of that Patient as of now, the only thing we can do with this patient is to follow this patient, for overall survival. Also, the hospital, a few short time back, reviewed The lesions they had included in for imaging, and they decided that 1 of the 2 lesions For this patient, it should be excluded. So we ended up with only 1 lesion for this patient. And that Lesion has decreased with 27%. The limit for a partial response is 30%.
And we are not able to have new images of this patient because the patient do not want to be followed up with images going forward. So that is unfortunate, but this is nothing special about clinical trials. This happened both in the negative and positive direction. Also, I would like to include that the cohort 2 data in a way, They are in line with the cohort 1 data, so we are not concerned about this reclassification in any way.
Thanks, Jens. And then we have one question on patient recruitment. When do you estimate that you will need to reach Last patient first visit in order to meet the second half twenty twenty two readouts for Initiam and NIIB. Will the current pace be sufficient or does it need to accelerate? And is your assessment that the pace will accelerate in the quarters ahead pending the impact of the pandemic?
Yeah, I can take that question. Thank you for the question. I think, you know, what what we can say, and the initial is the, of course, the study that we are in in full control. We can see that we have now the 38 Centers activated the last ones were in July. So at the moment, we are waiting to see the impact when all these centers are now active and enrolling, to see, you know, the next quarter, What is the movement?
So, you know, at the moment, we have no reason to change one way, one direction or the other, the guidance. You know, we may need to, and we will reassess the situation at the end of this quarter, because that will give us a little bit more a representation of what is really happening, because now, all all centers are are open. So, you know, at the moment, we maintain the guidance until we get more information. And we also have to see if, If the situation around the COVID pandemic changes in any way, we have a multitude of countries and centers involved that I say 38 centers. So we need, we need to see if that has an impact.
At the moment, we have not So enough information to say to change one direction or others, we maintain our guidance.
Okay. Then we have one question on, EV1 for the clinical development opportunities. It reads, keynote 17 sorry, keynote 716 read out positive data with pembrolizumab for patients With Stage 2 resected high risk melanoma earlier in August, what are your thoughts on the potential to move EV1 into Earlier stages of disease in the future, will this only be explored following approval in the settings currently on the trial in the ongoing Phase 2 program?
Jens?
So for UB1 And development of VIVO1, we have in Urdumax up until now, and I guess also in the future, a few rules. And one of those rules is that, the tumor as such must express telomerase to be an interesting indication. When we look at the 4 indication we are developing now, all those indications will have tumors that express telomerase. That is very important so that the T cells we are expanding have something to bind to. The other part is that we have seen now over the last decade that the checkpoint inhibitors have done a Tremendous job in a part of the patients, around 1 third of the patients, where they, in a way, open the tumor for the T cells.
For us, therefore, it's very important to develop our drug, the vaccine, together with the checkpoint inhibitors, meeting those 2 classes below together. We can see now that the development of Checkpoint inhibitors are moving earlier to earlier stages. It's in some of the indications like in malignant melanoma. It's already in, adjuvant setting. And also, there are, clinical studies ongoing, prior to operation, neo adjuvant.
And this is also happening in other indications. For us, it's important to develop the vaccine At the same stage as the rest of the world are developing the checkpoint inhibitors. So when the checkpoints inhibitors are moving earlier, That is also a natural way for a vaccine our vaccine to be developed. So Hopefully, we can move into earlier stages in the future. And then that might also be of a benefit to a vaccine where the tumor is not that advanced.
Thanks, Jens. Then a question on, regulatory designations. Will you use your current melanoma data to apply for breakthrough, designation Or will this happen later?
Well, without, thank you for the question without necessarily, Talking about 1 or the other designation, we will use the data and together with our advisors to to consider then, going in this particular case to the FDA, to, to see, about, requesting a designation. So, we are working on that. And as you know, we will communicate when we have facts. So, of course, as a company, that is something that we definitely need to Florian, we are
doing it. Thanks, Carlos. Then, one question related to IPR. Regarding the patent situation, any comments on the recent final rejection, on the application Avaxin in combination with an immune checkpoint inhibitor for use in treating cancer?
Well, you know, I don't have, full details there, you know, but I think, as a general comment, We have patents for UV1 that are granted, the core patents, that's the most important. As a company, we also explore different avenues in terms of gaining new patents. So we have multiple Patent applications, and all of these applications are, as you can imagine, very complex processes. So, some, some of these applications will be rejected. Other ones will be approved.
Some of ours will need to be modified. So this we are doing our job in terms of increasing the pool of patents. And we will communicate when we have patents granted. So it's very difficult to comment on very specific patterns individually. So we are not going to comment on that.
But I think just to Summarize the key part here is that all our core patents for UV-one are granted.
Thanks, Carlos. Then there is one question related to the TENDER trial. There is a 10 times jump in dose from cohort 1 to cohort 2 in the tender trial. What should we expect if the trial continue to cohort 3? Will it be another 10 times jump in dose or a much smaller increase in dose?
So this is predefined. So The first dose was, as I stated, 40 micrograms. Now it will be 400. And if the safety is fine in the 2nd cohort and we move into the 3rd cohort, the dose will be 9 60 micrograms. So It will be a doubling of those from the second to the third cohort.
Yeah.
Thanks, Jens. Then back to the Phase 1 trial in melanoma. How many patients in Cohort 2 in the Phase 1 melanoma trial completed 8 versus 7 versus 6 doses? Or can you comment on whether there was any meaningful difference versus Cohort 1 where you presented this data?
So this data this question, this is not disclosed as of now, the number of Doses, we will come back to that. We will start to work on a publication together with the investigators for this trial. And there will be more granulated data in such updates. As a general comment, we See very few differences between the cohort 1 and cohort 2, both when it comes to safety. And with safety, I then mean both the clinical safety and also the impact that safety do on treatment as such.
So the profile in cohort 2 and cohort 1 is very similar. And also on the efficacy We have seen the same trend. But remember that for both these cohorts, even if we are very happy with these results, This is still 30 patients. So to compare the different cohorts too much might lead to So kind of a deviated understanding of the true results. But we are very happy seeing that the by Cohort 1 results.
Thanks, Jens. One new question related to the same trial. If I am correct, according to the clinicaltrials dot gov, the official length All the Phase 1 melanoma study is 24 months. Do you expect you will have the progression free survival data from both cohorts by that time? Can you continue follow ups later?
So, that is true. So, for this trial, it's defined for 2 years. If we will reach median PFS for the whole trial or not within those 2 years, we don't know as of now. It's likely that the patients will be followed for survival as in the early Phase 1 trials over the next few years. But remember also that a 2 year information, even if it's not medium PFS, but a higher number then, will be great information for us.
And also, as you know, we have already, in a way, moved further, so we are now in Phase So this Phase I trial is happy news for us, but we have already moved into Phase II with a relevant design To test the vaccine in this cancer population.
Yeah. And Jens, you know, as As all you said, you know, we, we don't know what is going to be the, the ultimate to median PFS and when it's going to be reached, but We basically are already above the medium PFS of pembrolizumab alone. So we'll always be better. What is good news, of course.
Okay. Then we have the last question, which is related to licensing of UVA1. Will it be theoretically
Well, in theory, anything is possible. You know, as a company, of course, and as communicated, we are in continuous Dialogue sharing the data with different groups of potential partners. I think, we basically, as also publicly communicated, we look at the Phase 2 Data has the key data to also potentially give us the best deal. But of course, if, if any Pharma company is interested in, in licensing before that. We will, of course, listen to it, consider the offer and see if basically it represents the true value and the potential that we see for UV1.
So, we, we believe that the best deal will be with the phase 2 data, but It's a very dynamic space, as everybody can see, with a lot of deals happening. And of course, we will consider that if someone is interested.
Thank you. Then there are no more questions.
Good. If there are no more questions in a way, I want to thank you for All your attention and all your questions was a very, very interested group. So we appreciate that. And again, a big thank you to, and the team that is very dedicated to Ultimavax and really delivering results that have an impact on patient's life because we shouldn't forget that, you know, we are treating Human beings, you know, that have cancer and, we really thrive to to make a difference in in patients' lives. So that's really our core objective.
But of course, it's important to get the engagement of the team, but also the support from our board and all of our Investors and shareholders, so a big thank you to all of you and we look forward to communicate with you in the next quarter and in other different opportunities. So, we wish you a good rest of the day and we want to thank you for Your interesting questions. Thanks, Hans, and thanks, Jens. Thank you.