Good morning, everybody, and welcome to Ultimavac's First Quarter 2021 Presentation. My name is Karsten Sousa, I'm the CEO, and with me are Jens Bierheim, that's our Chief Medical Officer and Hans Vasgord Ayed, that is our Chief Financial Officer. If we can move to the next slide. So I need to show you this disclaimer, but 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 Q1.
Jens will continue with the operational update, and Hans will cover the key financials for the Q1 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 Ultimavax. We started the year in a very positive note when we announced the DOVAC trial, where finally we could announce the collaboration study with the Nordic Society of Gynecological Oncology and AstraZeneca in ovarian cancer patients. So when we put together the INITIUM trial, the NIIITIUM, DOVAC, and FOCUS trial, we have now an ambitious Phase 2 program with 4 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-nineteen pandemic. Has been a lot of stress and impact on everybody's life, you know, our daily lives, but 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 patient situation and cancer patients are naturally afraid of going to hospitals, Difficult in transportation so 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, you know, due to the COVID 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 ISSUE we have now 40 patients versus The 24 as previously announced in the last quarter, in the NIP we have 29 patients and also we reached the first three patients in the first cohort of the TENDU study.
So 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, you know, 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 extract of our Phase 1 trial evaluating our universal cancer vaccine, UV-one, in combination with a 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, and the annual meeting will be held virtually from the 4th to the 8th June of 2021. I will cover a little bit more all the activities that we are doing around this event. So moving to the operational update, I give the word to Jens.
Jens, please.
Thank you. Good morning. Let's go to slide number 8. This slide presents an overview of the development pipeline in Ultimavax. For the UV1 product, We have in total 8 clinical trials, 4 Phase 1 trials and 4 Phase 2 trials.
The 3 first phase 1 trials were started several years back and are in long time follow-up these days. From all these three trials, we have reported 5 year results. For the 4th Phase 1 trial, as Carlos just Mentioned, we reported top line data from the 1st cohort in this study last year. And we are happy to present 18 years landmark data on ASCO now in the start of June. We also are part of 4 Phase 2 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 TENDER study, I will also touch on that over the next slides. If you go to slide number 9, In this slide, you can see the INITCEN trial and the NEPA trial. The INITCEN trial is the Ultimavax sponsored trial In first line advanced malignant melanoma patients, in this study, we recruit patients from Norway, Belgium, UK In U. S, totally 154 patients will be included in this study.
Eberpore started to include patients last June. In this study, all patients will receive nivolumab and ipilimumab and in the intervention arm also UB-one 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 NIIPA trial and The NIIPA trial is a second, it's a Phase 2 trial in malignant pleuromethoteloma. 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 the BMS and ourselves to include 118 patients in Scandinavia, Spain and Australia. Also in this trial, 1st patients were was included in June last year. As for the Initsum trial, the drugs used in this trial is nimulimab and ipilimumab in both arms.
And then on top, UB-one in the intervention arm. Also in this trial, PFS is the primary endpoint And the study readout will be second half of twenty twenty two. If you go to slide number 10, These are the 2 new trials, the DUVAC trial that was reported or announced In Q1 this year and the FOCUS trial that was announced Q4 last year. The DOVAC trial is a Phase 2 trial in women with ovarian cancer. It is in patients with 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 2 lines of chemotherapy. So 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. So the study is so called maintenance treatment of the patients that had effect from last line of chemotherapy.
The study is sponsored by NSGIO. That is the Nordic Skin Cancer Organization working with clinical trials In the Nordic region and also 2 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 skin cancer studies. There are also some sites in the U. S. That are part of the ENGOT umbrella. The study is a 3 armed study.
All patients receive ulapatib, the PARP inhibitor from AstraZeneca. In arm C, the patients also receive durvalumab, which is a PD L1 antibody and the vaccine, UV bond. The main statistics in the trial is between arm A and arm C. And primary endpoint in this study It's PFS as for the previous 2, 1, in its own Nippe. Top line results are expected in 2023.
There is also an arm B in this study with ulaparin and durvalumab. The reason for this It's for numerical reasons because there are some trials that are shown that combining ulaparib and durvalumab in this patient group Gives some extra efficacy as compared to ulaparib alone. It's also for generating hypotheses for the future. The last Phase 2 trial is the FOCUS trial. That is a randomized Phase 2 trial in patients with metastatic or recurrent PD L1 positive head and neck cancer.
The trial is sponsored by Halle University Hospital 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 to 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 6 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. So, the TET platform is a new generation vaccine technology Where the adjuvant, remember, we use now GM CSF in combination with UV1.
Here with this platform, the adjuvant and the peptides is combined in 1 molecule. We expect from this platform 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. And the part of the molecule here in the TED platform that we call the adjuvant part has a sequence that these antibodies can recognize.
So 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. But 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 TENDER trial. The TENDE trial is a 1st in month 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 TEND constructs. One hospital is part of this study, Oslo University Hospital, and between 9 12 patients will be included in the study And based on the information we get back from the different dose levels. As of Q1, we have recruited all patients in the first The cohort, that means all patients at the lowest dose. And we expect to continue. We will monitor these patients And we'll continue enrollment, if everything is okay.
Expected enrollment of cohort 2 will start over the in the summer.
Okay. So 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. And we see that total operating expenses in the Q1 of 2021 amounted to NOK 31,000,000 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 CHF 12,000,000 this quarter compared to SEK 10,000,000 in the Q1 of 2020.
The main drivers behind that A slight increase is 2 more employees and somewhat higher share option costs. If we look at R and D expenses, We see that the total R and D expenses in the Q1 this year was SEK 16,000,000 compared to SEK 18,000,000 in the same quarter last year. We should then keep in mind that in this Quarter, we received public grants of NOK 2,200,000,000. So I'm adjusting for that. We are at the same expense level as 1 year back.
When we look at other operating expenses amounting to NOK 3,000,000 that's at the same level as the previous year. During the Q1 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 euros. So we have converted NOK 50,000,000 €2,000,000 in cash or as a bank deposit. And in addition to that, we have also entered into Currency future contracts in euro, our total amount of NOK 100,000,000.
That conversion was made at a spot rate of 10.18 and this future contract will be swapped on a monthly basis. So we have then made a total conversion of NOK 150,000,000 to euros 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 Difference between market rate and the rate in the contracts. So during Q1, we generated a loss of NOK 1.6 Of course, this is a timing thing. When we Actually, we have a similar cost in the future.
We will get a lower cost than we otherwise would have done. So Adjusted for net financial items, the total profit or the total loss as we have no revenues For the quarter amounted to NOK 33,800,000 compared to NOK 30,300,000 in the same period the previous year. By the end of the quarter, we had a total cash holding of NOK 409 1,000,000. If we move to the next slide, slide 15, we are showing the operating cash flow, which is a negative amount. And 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 and 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 2 trials and also increase patient recruitment and other R and D costs.
Slide 16 It's mainly details to assist analytical work, so we're not going to Spend time on that in this presentation. So we can move to slide 17, where we show the expected news flow the end of this year. And in the last two Phase 2 trials, We expect to recruit the 1st patient in both these trials around mid year as Jens also described. Then as Carlos presented, We have we will announce the data from the Phase 1 trial We will combine UV1 in pebrolizumab in malignant melanoma and we have this abstract approved for presentation at ASCO Early June and the abstract itself will be announced on May 19th. We'll come back to that in some more detail on the next slide.
Then during the fall, we will have more data from that trial. So in Q4, we will present 1 year data from the 2nd cohort of that trial and 2 year data from the 1st cohort. Then moving on to the TED platform and the TENDO 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, because 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 o'clock at night, 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 20th a webcast where we will be discussing the data from this abstract. Normally, a lot of these presentations Where happened around ASCO, but 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.
So, the poster will include landmark 18 months data. This means that all patients Past at Least 18 months follow-up. I was already Scheduled to be presenting, participating, I will participate in a panel on the at the SACS Immuno Oncology Forum, but I will also have a presentation on 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, this 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 ready schedule, we are presenting the following week at the ABG Life Science Summit seminar And also, Beostock is also virtual, summit, the Beostock Investor Summit.
This is primarily targeted at the Swedish market, but of course any investor also in Norway can register. And I will be having also a presentation on the company and the abstract data at this Summit. And then on June 4th at 15 European Time and ASCO will then release the full data from the posters. And then we will also put in our website the poster presentation from the presenter and one of the lead investigators in this trial. So, a very busy schedule, but Important, as I said, to give an update on the new data and give you 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 a small biotech, we should be proud of the ambitious and broad Phase 2 program that now has extended to 4 trials. We will have more than 500 patients enroll in this Phase 2 Trials in different indications and in different combinations. What is that 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 challenges of the COVID-nineteen pandemic, we continue to engage new sites and increase the patient recruitment in the INITIUM and the Nippo trials, and we expect that with some normalization of life, you know, 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 I have the Phase 1 data in combination with UV-one and pembrolizumab in metastatic melanoma at ASCO Annual Meeting, and also that we have moved from the preclinical to clinical with the TENO study.
As Jens mentioned, You know, we have now the first three patients in the first cohort enrolled, and the next step is for independent safety Advisory Board to review the data and give the okay to move to the next cohort. And of course, we will keep you updated on these events. And as also Hans mentioned, we expect to have towards later in the year some of the initial data on safety. So Again, a very good start of the year despite all the challenges that we all face in our daily lives, and of course, we continue to be Totally engaged and excited of moving all our studies in all our projects ahead through a very dedicated team and also keeping, you know, the major objective and our goal is to really bring therapeutical alternatives to cancer patients, and we think that we are doing that through the dedication of the team. So I want to thank you all for your attention.
And we will move now to the Q and A in the next slide.
Yes. We have received a few questions regarding the clinical trials. So I'll start with the first one. The NIIPA 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 equipment?
So, We have just recently discussed or asked the principal investigator of We tried to update the clinical trials. So the exact numbers will appear on the clinical trials 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. And we will still continue to open a few more slides over the next months, but the clinical trials will be updated.
Thanks, Jens. And here, I just want to take an opportunity to make a comment. As you know, the NIPL trial, the Duvac trial and the FOCUS trial are investigate initiated studies. It's their responsibility to give this update, but of course we work closely with them to make sure that, You know the clinicaltrials.gov site is updated.
Okay. Thanks Jens and Carlos. Next question. Top line data is expected in the second half Call 2022 for Inisham and Nepo. 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.
Okay. Thank you. So both the Initian and NIIPU and also actually the Duvac Trial is so called endpoint driven drives. 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, you know, and just to complement, as Jens mentioned, the primary endpoint It is a medium PFS, but event driven, and so we need to have that these events, the number of events predefined are reached and only at that time, you know, we can really communicate some of the top line results. And of course, The better is the efficacy, the longer it will take to reach those predefined number of endpoints. So 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, you know, on a proper and professional way.
Okay. Next question. When do you expect to need to complete last Patient first visit for the Inetian and NIIPA trials in order to keep to the second half twenty twenty two expected readouts, Taking into account the necessary follow-up and so on.
You know, we at the moment, we want to continue Keeping an eye on the development, you know, and 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, and as we progress during the year, then we will be in a much better position to say, Depending on when the last patient is enrolled, to be able to give better indication again, assuming that the number of events are not to Anatolay when we expect to get top line results. So I think I would ask everybody to Have a little bit of patience, you know, we have to see now how the society and the hospitals, you know, respond to the and now extended vaccination of patients and the lockdown measures. So, you know, 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 initiative and the status 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?
Again, each country It's different in hospitals. What we see is now that we start to have more hospitals, Centers in hospitals are now activated, including the UK. So the team will continue working diligently with these centers to activate More sites and again, probably the next quarter of report will be a better time to give you more better indications how the situation evolved. But yes, we are opening more sites and enrolling patients. You know, it's as expected, you know, is a challenge to all the industry, all the biotechs, But I think we are doing quite, 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 test program. For the TET program, can you comment at all on what the preliminary development plan looks like following the tender study? Or when you expect to be able to give more details on this? And 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 data will come, the funnel data will come in 2022, but we will be able to, particularly to have initial indications of the safety and immune activation at the lower doses towards the end of this year. So You know, this will already start giving us some indications, but the study itself, because there are other cohorts coming after, We'll come in 2022. Regarding the plans for TET, Too early still to say. We are continuing with preclinical activities and looking also at CMC, And, you know, when we are ready to inform the market, you know, we will do it, But again, you need to be a little bit patient. As mentioned before, we also, as also mentioned, We 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 patterns, you know, in review, and we need to be very careful not to disclose any information that could impact to the receiving those patents.
So 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.
Then there are no further questions.
Okay. If there are no further questions, I want to thank Everybody for spending with us the last hour and also to Jens and Hans for the support and also a big thank you to the whole team at Ultimavax that has been working very diligently despite all the challenge in terms of working from home, But we have been delivering, and I'm very proud of the team, and also a big thank to our shareholders for their support of the company, and also the Board that has been working very, 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 in continuing to deliver. And 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.