Good morning, everybody, welcome to Ultimovacs first quarter 2021 presentation. My name is Carlos de Sousa, I'm the CEO. With me are Jens Bjørheim, that's our Chief Medical Officer, and Hans Vassgård Eid, that is our Chief Financial Officer. If we can move to the next slide. I need to show you this disclaimer. Let's move to the next slide and tell you what are we going to cover today. I will start by giving some of the highlights of the first quarter. Jens will continue with the operational update, and Hans will cover the key financials for the first quarter 2021 news flows, and I will finish with the key highlights. If we move to the next slide. Q1 of 2021 was another very successful quarter for Ultimovacs.
We started the year in a very positive note when we announced the DOVACC trial, where finally we could announce the collaboration study with the Nordic Society of Gynaecological Oncology and AstraZeneca in ovarian cancer patients. When we put together the INITIUM trial, the NIPU, DOVACC, and FOCUS trial, we have now an ambitious phase II program with four trials that will have more than 500 patients enrolled. Jens will give you full details of these studies in his part. If we move to the next slide. I think we, of course, all are impacted by the COVID-19 pandemic. It has been a lot of stress and impact on everybody's life, our daily lives. It has been a particular significance to hospitals and patients.
Hospitals, of course, have to deal with not only the normal patients but also the COVID-19 patient situation. Cancer patients are naturally afraid of going to hospitals, difficult in transportation. Has been a big impact for the industry in general. It's not just for us, for everybody, in terms of being able to recruit patients due to the COVID-19 pandemic. Nevertheless, we are quite pleased and happy that despite all these challenges and due to the very hard work of Jens and our clinical operations team, we have been able to continue enrolling patients and activating new centers. In INITIUM we have now 40 patients versus the 24 as previously announced in the last quarter. In the NIPU we have 29 patients. Also we reached the first three patients in the first cohort of the TENDU study.
Despite all the challenges, we continue extremely dedicated to make sure working with the centers and with the CRO to have patients enrolled. Of course, we expect that with the rollout of vaccination, life will start coming to some degree of normality, and hopefully in the second half of the year, all these enrollment rates will accelerate. If we move to the next slide. We are also very honored and pleased that the abstract of our phase I trial evaluating our universal cancer vaccine UV1 in combination with the checkpoint inhibitor pembrolizumab in patients with metastatic malignant melanoma has been accepted for a poster presentation at the biggest oncology medical conference in the world, the American Society of Clinical Oncology, or ASCO. The annual meeting will be held virtually from June 4th-8th, 2021.
I will cover a little bit more all the activities that we are doing around this event. Moving to the operational update, I give the word to Jens. Jens, please.
Thank you. Good morning. Let's go to slide number eight. This slide present an overview of the development pipeline in Ultimovacs. For the UV1 product, we have in total eight clinical trials, four phase I trials and four phase II trials. The three first phase I trials were started several years back and are in long time follow-up these days. From all these three trials, we have reported five-year results. For the fourth phase I trial, as Carlos just mentioned, we reported top line data for the first cohort in this study last year. We are happy to present 18 months landmark data on ASCO now in the start of June. We are also a part of four phase II studies. I will come back to these studies on the next slides.
For the TET platform, we have moved from preclinical science into the first clinical study through the TENDU study. I will also touch on that over the next slides. If we go to slide number nine. In this slide, you can see the INITIUM trial and the NIPU trial. The INITIUM trial is the Ultimovacs-sponsored trial in first line advanced malignant melanoma patients. In this study, we recruit patients from Norway, Belgium, U.K., and U.S. Totally 154 patients will be included in this study. This report started to include patients last June. In this study, all patients will receive nivolumab and ipilimumab, and in the intervention arm, also UV1 on top. The primary endpoint in the study is progression-free survival, and we expect to report on top-line results second half of 2022. For the NIPU trial, the NIPU trial is a phase II trial in malignant pleural mesothelioma.
It's a second-line treatment. It means that the patients have received chemotherapy first line and then progressed on that. Sponsor for this study is Oslo University Hospital. They collaborate with BMS and ourself to include 118 patients in Scandinavia, Spain, and Australia. In this trial, first patients was included in June last year. For the INITIUM trial, the drugs used in this trial is nivolumab and ipilimumab in both arms, and then on top UV1 in the intervention arm. In this trial, PFS is the primary endpoint, and the study readout will be second half of 2022. If you go to slide number 10, these are the two new trials, the DOVACC trial that was reported or announced in Q1 this year, and the FOCUS trial that was announced Q4 last year. The DOVACC trial is a phase II trial in women with ovarian cancer.
It is in patients which have a BRCA negative status. That means for some of these patients, they will have a positive BRCA mutation, around 15% of the patients. The rest of the patients will be BRCA negative, and this study is for the BRCA negative patients. The patients that will be included in the study are those that have received two lines of chemotherapy. They have first received one line of chemotherapy, and when they progress on that one, they will receive a second line of chemotherapy, and if they have effect from that second line of chemotherapy, they can be included in this study. The study is a so-called maintenance treatment of the patients that had effect from last line of chemotherapy.
The study is sponsored by NSGO, that is the Nordic Gynaecological Cancer Organization, working with clinical trials in the Nordic region and also the two of the Baltic countries, Estonia and Lithuania. They collaborate with AstraZeneca and ourselves to include 184 patients from 10 European countries. They will start to include patients in this study from mid-year over the next months. Right now, they are working towards the authorities to get the study going in the different countries. Also interested and part of this study is the ENGOT organization. ENGOT is an umbrella organization for collaborative groups in Europe that work with gynaecological cancer studies. There are also some sites in the U.S. that are part of the ENGOT umbrella. The study is a three-armed study. All patients receive olaparib, the PARP inhibitor from AstraZeneca.
In arm C, the patients also receive durvalumab, which is a PD-L1 antibody, and the vaccine UV1. The main statistics in the trial is between arm A and arm C, and primary endpoint in this study is PFS as for the previous two, INITIUM and NIPU. Top-line results are expected in 2023. There is also an arm B in this study with olaparib and durvalumab. The reason for this is for numerical reasons, because there are some trials that have shown that combining olaparib and durvalumab in this patient group gives some extra efficacy as compared to olaparib alone. It's also for generating hypotheses for the future. The last phase II trial is the FOCUS trial. That is a randomized phase II trial in patients with metastatic or recurrent PD-L1 positive head and neck cancer. The trial is sponsored by Halle University Hospital (Saale) outside of Berlin.
This is a purely German trial with 10 sites in Germany that will include 75 patients. The first patient to be included in this trial is also expected over the next months, and the top-line results are expected in 2023. In this trial, in both arms, the patients will receive pembrolizumab, and in the intervention arm, they will receive UV1 on top. It's a 2:1 randomization in this trial, 50 patients in the intervention arm and 25 patients in the control arm. PFS is also here the primary endpoint, but here it is as a landmark endpoint. After six months, there will be a readout of the PFS in this study. If you go to the next slide. We have previously presented parts of the TET platform.
The TET platform is a new generation vaccine technology where the adjuvant, remember we use now GM-CSF in combination with UV1. With this platform, the adjuvant and the peptides is combined in one molecule. We expect from this platform a beneficial safety profile and simplified administration. The mode of action or the theory around this platform is that for most patients, they will have vaccinations against tetanus. When you are vaccinated against tetanus, you will develop antibodies that you have already in your body. The part of the molecule here in the TET platform that we call the adjuvant part has a sequence that these antibodies can recognize. When we inject the molecules from the TET platform in the patients, there will already be antibodies in the body that will bind to these molecules and actively take them up in the antigen-presenting cells.
This platform has been in preclinical development until recently. As we have announced earlier, we have moved into a clinical study. If you go to the next slide, number 12. We started in Q1 the TENDU trial. The TENDU trial is a first-in-man trial with this platform. It's a dose-finding trial, and the primary endpoints in this trial is safety and also immune responses generated from these TENDU constructs. One hospital is part of this study, Oslo University Hospital, and between nine and 12 patients will be included in the study based on the information we get back from the different dose levels. As of Q1, we have recruited all patients in the first cohort. That means all patients at the lowest dose. We expect to continue. We will monitor these patients, and we will continue enrollment if everything is okay.
Expected enrollment of cohort 2 will start in the summer.
If we move on to the financial section, slide 13. We believe there should be no surprises when looking at the numbers for this quarter. We can move to slide 14. We see that total operating expenses in the first quarter of 2021 amounted to NOK 31 million, and that's at the same level as the same quarter in last year. If we look at the more specific items behind that, we see that payroll expenses amounted to NOK 12 million this quarter, compared to NOK 10 million in the first quarter of 2020. The main drivers behind that slight increase is two more employees and somewhat higher share option costs.
If we look at R&D expenses, we see that the total R&D expenses in the first quarter this year was NOK 16 million, compared to NOK 18 million the same quarter last year. We should keep in mind that in this quarter, we received public grants of NOK 2.2 million. Adjusting for that, we are at the same expense level as one year back. When we look at other operating expenses amounting to NOK 3 million, that's at the same level as the previous year. During the first quarter this year, we have taken some measures to reduce the foreign exchange exposure. We have a significant proportion of the expected expenses in our large trials and projects in foreign exchange, in particular EUR. We have converted NOK 50 million to EUR in cash or as a bank deposit.
In addition to that, we are also entered into currency future contracts in EUR of a total amount of NOK 100 million. That conversion was made at a spot rate of 10.18, this future contract will be swapped on a monthly basis. We have then made a total conversion of NOK 150 million to EUR to reduce that currency exposure. Entering into this exposure and these contracts, we need, of course, on a quarterly basis, to account for the change or the difference between market rate and the rate in the contract. During Q1, we generated a loss of NOK 1.6 million. Of course, this is a timing thing. When we actually have a similar cost in the future, we will get a lower cost than we otherwise would have done.
Adjusted for net financial items, the total profit or the total loss, as we have no revenues for the quarter, amounted to NOK 33.8 million compared to NOK 30.3 million the same period the previous year. By the end of the quarter, we had a total cash holding of NOK 409 million.
If we move to the next slide 15, w e are showing the operating cash flow, which is a negative amount. We see, as we have described also on the previous slide, that the cash flow level is at the same level as the last year. We do expect an increase in the operating expenses and the negative operating cash flow later in the year as we initiate the last two phase II trials, and also increase patient recruitment and other R&D costs. Slide 16 is mainly details to assist the analytical work, we're not going to spend time on that in this presentation. We can move to slide 17, where we show the expected news flow the end of this year. In the last two phase II trials, we expect to recruit the first patient in both these trials around mid-year, as Jens also described.
As Carlos presented, we will announce the data from the phase I trial, where we combine UV1 with pembrolizumab in malignant melanoma. We have this abstract approved for presentation at ASCO early June. The abstract itself will be announced on May 1 9th. We'll come back to that in some more detail on the next slide. During the fall, we will have more data from that trial. In Q4, we will present one-year data from the second cohort of that trial and two-year data from the first cohort. Moving on to the TET platform and the TENDU trial where we have recruited the first three patients now. We will, during Q4, have the interim readout of safety data and immune activation data. Thank you.
Thank you, Jens and Hans. If we can move to slide 18. The team is going to be very busy in the next couple of months, I wanted to give you a more detailed presentation on the communication of data. As was already referred, on May 19th at 11:00 P.M. , ASCO will release the abstracts from the posters and presentations, and we will have a press release where we will give the details of the abstract. We will have then on the 20th a webcast, where we will be discussing the data from this abstract. Normally, a lot of these presentations happen around ASCO.
Because of the fact that these events now are primarily virtually, there are some changes and we will be then discussing at this time the data because we think this is important that our investors and shareholders really have a good understanding of the data. The poster will include landmark 18 months data. This means that all patients passed at least 18 months follow-up. I was already scheduled to be presenting, participating. I will participate in a panel on the 19th at the Sachs Immuno-Oncology Forum, but I will also have a presentation on the 20th. Because of the time difference will be late in the afternoon European time, where will be the first forum where I will be able to present the data from the abstract.
Also that afternoon, we will participate in the Radium podcast also to give the opportunity for the listeners and our investors to ask questions from myself and other members of the team. Also already scheduled, we are presenting the following week at the ABG Life Science Summit seminar, and also BioStock is also virtual summit, the BioStock Investor Summit. This is primarily targeted at the Swedish market, but of course, any investor also in Norway can register. I will be having also a presentation on the company and the abstract data at this summit. On June 4th at 3:15 P.M. European time, ASCO will then release the full data from the posters. We will also put in our website the poster presentation from the presenter in one of the lead investigators in this trial.
A very busy schedule, but important, as I said, to give an update on the new data and give also the opportunity to our investors and shareholders to ask questions during this process. Moving then to slide 19, I would like to highlight the key takeaways from this report. I think we should, as small biotech, we should be proud of the ambitious and broad phase II program that now has extended to four trials. We will have more than 500 patients enroll in these phase II trials in different indications and in different combinations. What is at the goal of our strategy of really showing that UV1 has the potential to be used across different cancer types and in combination with different classes of drugs.
Despite the challenge of the COVID-19 pandemic, we continue to engage new sites and increase the patient's recruitment in the INITIUM and the NIPU trials, and we expect that with some normalization of life, this recruitment will accelerate in the second half of the year. As I mentioned, we are very proud of having the opportunity to have a presentation of the phase I data in combination with UV1 and pembrolizumab in metastatic melanoma at the ASCO annual meeting. Also that we have moved from the preclinical to clinical with the TENDU study. As Jens mentioned, we have now the first three patients in the first cohort enrolled. The next step is for an independent safety advisory board to review the data and give the okay to move to the next cohort. Of course, we will keep you updated on these events.
As also Hans mentioned, we expect to have towards the later in the year, some of the INITIUM data on safety. Again, a very good start of the year despite all the challenge that we all face in our daily lives. Of course, we continue to be totally engaged and excited of moving all our studies and all our projects ahead through a very dedicated team and also keeping the major objective, and our goal is to really bring therapeutic alternatives to cancer patients. We think that we are doing that through the dedication of the team. I want to thank you all for your attention, and we will move now to the Q&A in the next slide.
Yes. We have received a few questions regarding the clinical trials. I'll start with the first one. The NIPU trial has not been updated on ClinicalTrials.gov since June last year, with still only one site open for recruitment. Can you tell us how many sites now are truly open for recruitment?
We have just recently discussed or asked the principal investigator of the trial to update ClinicalTrials.gov, so the exact numbers will appear on ClinicalTrials.gov over the next short future. I can say that we have open sites in different countries. We already have, as you know, we have open sites in Scandinavia and in Australia as of now. We will still continue to open a few more sites over the next months. ClinicalTrials.gov will be updated.
Thanks, Jens. I just want to take an opportunity to make a comment. As you know, the NIPU trial, the DOVACC trial, and the FOCUS trial are investigator-initiated studies. It's their responsibility to give this update, but of course, we work closely with them to make sure that the ClinicalTrials.gov site is updated.
Okay. Thanks, Jens and Carlos. Next question. Top-line data is expected in the second half of 2022 for INITIUM and NIPU. If at that point median PFS has not been reached, will you still report both overall survival and objective response rate to the market without delay?
Go ahead, Jens.
Thank you. Both the INITIUM and the NIPU, and also actually the DOVACC trial, is so-called endpoint-driven trials. That means that we wait for a certain number of endpoints to be reported before we make up the data. In a situation where the effect of the drugs, and that could be both in the control arm and in the intervention arm, are longer than expected, the information about the primary endpoint will be delayed. We will always wait for the predefined number of endpoints to be reached.
Yeah. Just to complement, as Jens mentioned, the primary endpoint is median PFS, but event-driven. So we need to have these events, the number of events predefined are reached, and only at that time we can really communicate some of the top-line results. Of course, the better is the efficacy, the longer it will take to reach those predefined number of endpoints. What it will be, look at it from a positive perspective, but when we have the data, we will communicate to the market as we normally do on a proper and professional way.
Okay. Next question: when do you expect to complete last patient first visit for the INITIUM and NIPU trials in order to keep to the second half 2022 expected readouts, taking into account the necessary follow-up and so on?
At the moment, we want to continue keeping an eye on the development with the COVID pandemic. I think it will be too early now to give any further guidance on when we will have the last patient enrolled. Every quarter, we will keep the market updated. As we progress during the year, we'll be in a much better position to say, depending on when the last patient is enrolled, to be able to give a better indication again, assuming that the number of events are not delayed when we expect to get top-line results. I think I would ask everybody to have a little bit of patience. We have to see now how the society and the hospitals respond to the now extended vaccination of patients and the lockdown measures.
Every quarter we will give you a better idea where we are in terms of patient enrollment, and then provide a proper, better guidance when we expect to get the data.
Okay. One more question. That seems to be the last one, unless there are other questions coming in. Can you comment on whether you have already started to see a pickup in recruitment in certain territories that you are running the INITIUM and NIPU studies in, considering that different countries are at different varying stages of the pandemic? Thinking about the U.K., for example, where infection rates have come down in line with the vaccine rollout.
Each country is different, and in hospitals, what we see is now that we start to have more hospitals, centers in hospitals are now activated, including the U.K. The team will continue working diligently with these centers to activate more sites. Again, probably the next quarterly report will be a better time to give you better indications how the situation evolved. Yes, we are opening more sites and enrolling patients. As expected, it's a challenge to all the industry, all the biotechs, but I think the team is doing quite a good job of maintaining the activities and increasing the number of patients and sites activated.
Okay. We have one other question coming in related to the TET program. For the TET program, can you comment at all on what the preliminary development plan looks like following the TENDU study, or when you expect to be able to give more details on this? When do you expect to complete this first study, 2021 or 2022?
Starting with the second part of the question, the study has different cohorts, so the final data will come in 2022. We will be able particularly to have initial indications of the safety and immune activation at lower doses towards the end of this year. This will already start giving us some indications. The study itself, because there are other cohorts coming after, will come in 2022. Regarding the plans for TET, too early still to say. We are continuing with preclinical activities and looking also at CMC. When we are ready to inform the market, we will do it. Again, you need to be a little bit patient.
As mentioned before, we also need to be, for the time being, also extremely careful in terms of how much we divulge around our plans for the TET platform because we have different patents in review, and we need to be very careful not to disclose any information that could impact receiving those patents. The important part here is that we continue moving along with the TET platform and particularly with the TENDU study that will give us valuable information to support the overall platform and new products coming out of this platform.
Yeah. There are no further questions.
Okay. If there are no further questions, I want to thank everybody for spending with us the last hour, also to Jens and Hans for the support, also a big thank you to the whole team at Ultimovacs that has been working very diligently despite all the challenges in terms of working from home. We have been delivering, I'm very proud of the team. Also a big thank to our shareholders for the support of the company, also the board that has been working very closely with management to make sure that we properly address all the challenges that every biotech faces in this environment, but supporting the team and continue to deliver.
We look forward really to the next couple of months where we'll have more opportunity to be communicating with you and talking about the data that will be presented at ASCO. I wish you a good day, and please do not hesitate to reach out to us if you have any other questions. Thank you, and have a good day.