Good day. Welcome to the Galapagos Q1 Webcast and Conference Call. Today's conference is being recorded. At this time, I'd like to turn the conference over to Elizabeth Goodwin. Please go ahead.
Thank you. Welcome all to our results call today. I'm Elizabeth Goodwin, Investor Relations. I'll be hosting the event. This recorded webcast is accessible via Galapagos website homepage and will be available for replay later on today. That your questions can be included, we request that you dial in to the number given in the press release from last evening. That's 32 for Belgium, 24040659. The code is 5747918. I remind you that we will be making forward-looking statements during today's webcast. These forward-looking statements include remarks concerning future developments of the pipeline and our company, and possible changes in the industry and competitive environment. Because these forward-looking statements involve risks and uncertainties, Galapagos' actual results may differ materially from the results expressed or implied in these statements.
Today's participants will be Onno van de Stolpe, CEO, Walid Abi-Saab, CMO, Piet Wigerinck, CSO, and Bart Filius, COO and CFO. We will begin with some PowerPoint slides followed by a Q&A session. With that, I'd like to hand over to Onno. Go ahead, Onno.
Thank you, Elizabeth. Welcome everybody to our webcast. We have decided to change the format of the webcast somewhat by making the official part of the presentation quite a bit shorter to allow more time for Q&A. I'll jump right in with the first slide about the delivery in Q1 2018. If you look at the inflammation part of our portfolio, we were very happy that filgotinib phase II trials in psoriatic arthritis and ankylosing spondylitis were fully recruited. Very pleased that that went ahead and on time, and we are awaiting the data when the results will come in. We also announced the target engagement in OA patients of 9072. Very pleased with the outcome of that, and that's the basis of the large phase II study that's being planned. We also announced the MOR106 results in atopic dermatitis at the AAD conference.
In IPF, we were very pleased that the FDA and the EMA agreed to our plans to move this program directly into a phase III program. We announced the planning of this program recently, and I'll come back to that. In cystic fibrosis, we completed our phase I study with the second triple. We also completed the recruitment of the PELICAN study, which is the combination of C2 with ORKAMBI. Finally, we got approval for the FALCON first triple combo trial. We'll be moving our first triple into CF patients, and I'll lay out the trial design later. On a corporate level, we announced a cash balance of $1.1 billion by the end of the quarter. Let's start with the phase III program, ISABELA for GLPG1690, our IPF program.
We will conduct two phase III programs for a total of 1,500 patients. All these patients will remain on standard of care throughout the trial. They will stay on drug throughout the whole phase III program until the last patient has been dosed. There will be two dosages tested. It's a 52-week trial, and afterwards it will continue in an open-label extension. The primary endpoint is forced vital capacity and a number of secondary endpoints in this trial. It's exciting for us. It's our first phase III that Galapagos will be running ourselves, and it is quite something that after one phase II trial, key opinion leaders as well as the regulatory agencies all supported the move of this program into a phase III registration trial. Very exciting for Galapagos. If you move to cystic fibrosis, the FALCON study, long awaited.
It has taken a long time before we got the approval from the authorities and ethics committee in the U.K., but everything is now in order. We can move forward with the recruitment of these patients and the opening of the centers. We'll have a trial design that's listed in this slide, where we start with a dual followed by a triple dosing, both of them for two weeks. We'll start with a first dose in homozygous patients, delta F508, and then followed by a second higher dose where we'll dose both in heterozygous as well as homozygous patients. Small cohorts, short dosing with that should be sufficient to give us a good view on the safety as well as the efficacy of the triple into patients.
Primary endpoints are safety and tolerability, of course, PK. Also very important to look at the efficacy levels in this trial. If you look out for the rest of the year, you'll see a number of late-stage trial initiations. We're nicely on track to execute everything there that we were planning to execute. A number of those trials will take quite a long time to recruit and of course, administer the drug. They will run for a long time. The good news is that we're also expecting a lot of trial results in the time to come. If we look at this quarter, we'll get a readout of filgotinib in psoriatic arthritis. We'll get the PELICAN cystic fibrosis study. Also important, we'll get the go, no-go with regard to filgotinib in ulcerative colitis, if it will move from the phase II into phase III.
We will not release data on that. It will just be an announcement that this trial has moved from a phase II to a phase III. We're expecting very shortly the full enrollment for FINCH 1 and FINCH 3, greatly ahead of the original scheduled timing. For the next half year, so after this quarter, very importantly, the first phase III trial will read out the FINCH 2 trial with filgotinib in RA. Also, the phase II trial of filgotinib in ankylosing spondylitis, and we'll get the first triple combo data of FALCON. A lot to look forward to. With that, I'm happy to hand it over to our CFO, Bart.
Thanks, Onno. Good morning everyone in the U.S. and good afternoon in Europe. Happy to give you the view on the Q1 financials as well. As usual, I'll start off with cash, which is a slide that many of you have seen before, but then with the updated numbers obviously for 2018. We've closed up the quarter with a cash balance of EUR 1.1 billion, down from EUR 1.15 billion at the end of December. Our net cash burn in our definition was EUR 40 million for that quarter, consisting on one hand of cash out, cash expenses of roughly EUR 60 million, and on the other hand, cash income from milestones of a little less than EUR 20 million. We've maintained our guidance, obviously in the first quarter, we're early on in the year, between EUR 220 million and EUR 240 million for the full year.
We're below the 25% mark after the first quarter. That's really due to two reasons. On one hand, obviously, as you can see, the offset of cash income from milestones. On the other hand, the expenses will be gearing up towards the later parts of the year when the ISABELA program will go online in full in the second half. Two other elements that have influenced our cash position to a lesser extent, a bit from capital increases. Those are related to warrant exercises. We have a currency translation effect, which is really not cash in the sense that it's not a cash expense, but it's a translation of our dollar position into euros due to the weakening of the dollar against the euro on average over the quarter. On the next slide, I'm summarizing the key other components of our P&L.
As Onno was doing in a shortened version compared to what we've done in the past. I'll take you through the P&L on this slide with the highlights thereon. Revenues are up by EUR 5 million to EUR 45 million. That includes roughly EUR 10 million of revenue recognition that is due or thanks to the implementation of IFRS 15, a new accounting guideline that has led us to evaluate our position vis-a-vis the Gilead and the AbbVie contracts at the opening balance sheet of 2018. We are recognizing roughly EUR 10 million in this quarter, and this will influence our top line positively for the next eight quarters, so until, let's say, the end of 2019 is our estimation. By roughly this amount to total roughly EUR 80 million of re-recognition under IFRS 15. This is all a bit complicated. It's really all accounting driven. There's clearly no cash involved.
This is all about when we recognize and how we recognize license income and milestones from those partnerships with Gilead and AbbVie. Our operating costs are EUR 77 million, they are higher by roughly EUR 25 million vis-a-vis the same quarter of last year. That increase is some that we've seen over the last sets of quarters and is really driven by the mid and late-stage pipeline and the significant number of phase II and phase III trials that we're actually running at Galapagos. Finally, net results down by EUR 24 million, mainly driven by the operating cost, but also this unrealized currency translation effect has a negative on our P&L, even though obviously this is not fully materialized until you expense it. With that, I conclude the financial comments.
There's clearly a lot more detail in our Q1 report available on the website, or I'm happy to take questions as well. With this, I'll hand it actually back over to Elizabeth to take us through the Q&A, for which Onno and I are available, but also Walid and Piet are available for taking any of your questions.
All right. Thank you very much, Onno and Bart. That does conclude the presentation part of our call today. Now I'd like to ask the operator, Claudia, to connect us to callers with questions for the team. Go ahead, Claudia.
Thank you. If you would like to ask a question, please signal by pressing star one on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, press star one to ask a question. We'll pause for just a moment to allow everyone an opportunity to signal for questions. We will take our first question from Anastasia Karpova from Kempen. Please go ahead. Your line is open.
Hi, two clarifying questions on the upcoming readouts. Mechanistically speaking, would you expect to have dramatically different efficacy in psoriatic arthritis compared to what tofa has shown due to lack of JAK3 inhibition? For the second, can you help me understand how aggressive is a futility threshold in the upcoming ulcerative colitis trial? Is that something very challenging ahead of available therapies or something more conservative? Thanks.
Okay. This is Walid. I guess I'll take both questions. First, let me start with the futility analysis. The point there is to compare each dose of filgotinib to see whether it's performing worse than placebo. If that's the case, you would meet futility. Essentially, the point is that the threshold is really not very high. In other words, it's very unlikely that we will be meeting that futility analysis. That's an important test that we needed to do. On your other question regarding mechanistically, whether we expect anything different than tofacitinib, I would expect we should be expecting at least efficacy as good as tofacitinib, but we are hoping that we're going to be better on the account that we are not as limited by the dose that we can give because of concerns with going to sort of non-selective hitting other JAKs.
We're quite hopeful that we will have efficacy better than tofa.
Thanks a lot.
We will now take our next question from Peter Welford from Jefferies. Please go ahead.
Hi. Yes, thanks for taking my questions. Got a couple really on the upcoming planned trials. Firstly, in cystic fibrosis, I was wondering if you could reveal the dosing schedule that you're going to be using for the different components in the triple. Particularly, I guess with regards to the potentiator, is there still a plan to do a loading dose on day one and then a lower maintenance dose? Should we understand in the higher fixed dose combination dosing that's going to be used in part two of the trial, is that a higher dose of both potentiator and corrector one? Is that just a different dose of the early-stage corrector that's going to be used in that SDC?
In a similar vein, for the GLPG1690 phase III ISABELA trial, I presume that one of the doses, either A or B, will be the dose that was used in the phase IIa trial. Can you give us some insights into what the other dose that was chosen will be? Will that dose be the same in both of the phase IIIs, will one phase III perhaps investigate a lower and the other a higher dose? I guess, curious with any sort of feedback you got on dose selection when you had the meetings with the regulatory authorities. Thank you.
Okay, Piet here. I will start with the question on the FALCON design. FALCON design is the first CF study in which we'll dose our fully homemade triple combo in CF patients. It's a design where we start with a dual lead in two weeks and then step up to triple for the remaining two weeks. Indeed, in this study, on day one, the patients will get a loading dose of potentiator and then a maintenance dose. As the trial is kept quite short in terms of dosing, it's important that we are as quickly as possible on the effective levels that we anticipate we'll have for both the dose A and the dose B. At this moment, we will not disclose which these doses are and what components we are escalating, but that will come then later with the data.
Walid, over to you for IPF then.
Okay. Thanks, Piet. The ISABELA studies are identical. Identical doses will be used in both trials. The top dose will be the one that we've used in our Phase II study. We're not disclosing at this point what is the other dose, which obviously is a lower dose in that trial. In terms of feedback, the design of the study, including the dose selection, was discussed with both the FDA and EMA. There was full support for our proposal. Based on that, we confirmed the trial that we moved forward with.
That's great. Thank you. I'll jump back in.
We will now take our next question from Brian Abrahams from RBC Capital Markets. Please go ahead.
Hey, guys, thanks very much for taking my questions and congrats on all the progress. A couple on IPF and then on CF. On the ISABELA studies, can you maybe talk about the decision to do both combination and monotherapy in both studies rather than testing those separately? How you think about sort of powering these studies, given you'll have patients both on and off standard of care, and whether you're stratifying for patients on the individual concurrent therapies versus not on Esbriet or Ofev.
Okay, you want me to answer this and then you'll ask the CF question, Brian?
Yes.
Okay. All right. Just to take a step back, IPF is really a severe disease. People, when they're diagnosed, their median survival rate is about two to five years after diagnosis, which puts this in the category of some of the bad cancers. As such, ethically, it's very difficult to do long enough trials to demonstrate efficacy on monotherapy or essentially changing the standard of care of these patients. They don't have one year of their lives to give us to do a placebo-controlled trial. This has been an issue that's been very clear to us when we talk to the KOL, when we talk to the Pulmonary Fibrosis Foundation, which obviously we work very closely with, and also when we talk to regulators. As a result, we decided to design a study to go on top of standard of care.
The way the standard of care is, we mostly have that information from the U.S. where the Pulmonary Fibrosis Foundation has a good assessment of the situation. We know that about a third of the patients are on pirfenidone, about a third, roughly, are on nintedanib, and a third are on neither pirfenidone nor nintedanib. That is a representative sample of the U.S. population, which is going to be forming the basis of how we're going to be doing our trial. Essentially, in our trials, we will make sure that we keep people on whatever background medicine they're on. If they're on neither, they can stay on neither and come into our trial. We will not be dictating any changes in their background therapy.
We make sure that we are adequately stratifying, because we don't want certain groups to be over-represented in one dose group or the other. We will be watching this very carefully, and it will be stratified in the trial. In terms of powering of the study, we also discussed this extensively with KOLs, with the health authorities as well. The consensus is that there's a certain level of change or effect that you need to see on top of either background therapy or no background therapy for this to be clinically meaningful. Anything in the 30, 40 mils over a year is very weak. Just to put it in perspective, the current treatments with nintedanib and pirfenidone usually have a reduction of about maybe 120 mils to 150 mils after a year.
Essentially, there's still room to grow, but anything less than sizable, about 80 mils per year, would be perceived as non-clinically meaningful. Even though you can demonstrate it in a large enough trial, it's not clinically meaningful. This is what we use as a guide to power our studies. Our studies are powered to detect with 90% power, which is typical of phase III, to detect an 80 mil difference from background of treatment. That's what we proposed, and the health authorities supported us with this.
That's really helpful color. Just real quick on CF. I understand you're not disclosing the specific doses in the FALCON study, but I guess I'm just sort of wondering, based on prior preclinical and clinical data, whether you would expect the doses being used in part 1 to be the therapeutic doses and maybe what you would see as an FEV1 bar for that part 1, and then perhaps how the results of the upcoming PELICAN readout would influence your dose selection plan for 2737 in the second two weeks when it gets added on. I'll hop back in the queue. Thanks.
Okay, Brian, I'll try to answer because you broke up for a moment while asking your question. The FALCON study. Part 1, we should be at around EC80, EC90 level with the first dose. We really should see efficacy. It's clear that the dose of 2222 is informed with what we've done up to nine patients, and which is well known to all of you. For that part, in fact, the only unknown there is whether our assessment of active dose of potentiators 2451 is right, but we've chosen a dose which should clearly give us a good signal in that population. PELICAN upcoming data, in principle, we don't need those data for the FALCON study to start. It's a study where we dose 2737 on top of ORKAMBI.
There, of course, the unknown is how big will be the impact of lumacaftor in terms of PK interaction of GLPG2737, as well there, based on study results on DDI study with rifampin. We hope to be at around EC90 for GLPG2737, but the big unknown will be on how accurate the rifampin data will predict the exposures we will observe then with the GLPG2737. If the exposure of GLPG2737 is high enough, we should see good efficacy, but that's an unknown, and that's what we will work out in that study. Thank you.
Thank you.
We will now take our next question from Adam Walsh from Stifel. Please go ahead.
Good morning. Thanks for taking my question. I guess this one's for Walid. In terms of both the tofacitinib and baricitinib AdComs, the FDA seemed to be focused on the doses tested in the clinical trial program, and it seemed like with an eye toward whether the sponsors had identified a minimally effective dose that avoids certain AEs. And obviously, in the case of baricitinib, the agency was focused on VTEs. With respect to filgotinib dosing in the ongoing clinical trial program, can you just remind us of the rationale for the doses you're currently testing and whether you're comfortable that you've selected the right dose?
Thank you, Adam. If you recall, in the filgotinib program, we did a dose range finding in phase II. Based on these data, the doses of 100 and 200 milligrams were selected. Those doses were reviewed and discussed with the agency at the time as part of the end-of-phase II meeting. They were approved and endorsed. What came clear in the AdCom is that the FDA wants to see a robust database to allow adequate decision-making for each of the doses.
I'm very pleased that this is exactly the plan that we and Gilead have put together, not only for RA but also for the IBD program, where we test fully 100 and 200 and not favor one versus the other, such that at the end of the day, we will have a solid database that will permit us to make the adequate risk-benefit assessment of each dose and be able to recommend whether one, the other, or both should be recommended for approval.
Okay, that's helpful. Just one follow-up, if I could, on the ISABELA phase III program and IPF. Can you just give us a rough idea when we might see first data from those trials?
Yeah, it's a tough question, Brian. At this point, I don't feel comfortable guiding on the time. For the simple reason is that there's no good way to estimate it. Now when we do our feasibility and talk to a number of people, they come back with some numbers based on their experience with pirfenidone and nintedanib in the past. We're dealing with a completely different situation right now. One, there's a vastly different appreciation of the disease that we have today compared to when both the studies with nintedanib and pirfenidone were conducted, the phase III programs. Number two, in our case, we are going on top of standard of care, whether you are on nintedanib or pirfenidone or you are not. As such, we believe that our inclusion/exclusion criteria are also vastly different.
I think we're not getting accurate, actually, results, and I don't feel like we should be guiding at this point before we start seeing in real-life how well we're doing with recruitment, and we will be able to come back with better estimates at a later date.
Fair enough. Thank you.
We will now take our next question from Bhumi Sevon from Credit Suisse. Please go ahead.
Hi, great. Thanks so much for taking my question, and thanks for the efficient call today. I appreciate it on a busy day. Just two things, one on the filgotinib side and then one on CF. On filgotinib, if you could just provide an update on the long-term safety study and timing around when those results would be available. Just to confirm, because we've gotten some questions, that that is a requirement before you can submit the filing to the FDA or not. If you can confirm that. Then going back to CF and the FALCON study, just with two four five one, I'm just curious if there's any special sort of safety requirements incorporated into that trial, given some of the previous discussion around the longer-lasting metabolites. Is there anything beyond what you normally would be doing in a trial of this sort?
Thanks so much.
May I ask a clarifying question? This is Walid. You said long-term safety?
The male safety trial for that.
The male safety trial. Right. The male safety trial is ongoing, as we talked about, as we discussed previously. We believe that we will have the right data sets by the time we are ready to file to be able to have a total package that would satisfy the FDA's requirement.
I'll comment then on the CF question. In the FALCON study, which is the first time we dosed GLPG2451 in phase II, it is logic that we want to follow up both safety and efficacy of GLPG2451 as long as the compound is around. What is foreseen in the protocol is that the patients will be invited to come to the center as long as we detect the long-living metabolite. The expectation that with a couple of months, that will disappear. That is what is foreseen currently, that we monitor the metabolite up to the moment where it disappears. Thank you very much.
We will now take our next question from Phil Nadeau from Cowen and Company. Please go ahead.
Good morning. Thanks for taking my questions, and congratulations on the progress. Just a couple on the design of the FALCON study. I was curious about a couple of things. First was on the two-week lead-in with the dual therapy. What is the rationale behind that? Is that to show the additive efficacy of the C2, or is that to get the dual therapies up to steady-state levels before adding the C2? That is the first question. The second question is, in Part A, why are you looking at only homozygous patients? Why not include heterozygous patients, Het/Min patients in Part A as well, or Part 1, sorry.
Thank you for the question on FALCON. The two-week lead-in dual and then two-week triple. Indeed, the reason for that is that we really want to see what the additional benefit is of the C2 to a dual therapy. If we would start with a triple therapy immediately, then whatever you can measure in terms of improvement at the end is a sum of the three, and it is impossible then to distinguish how much comes from the C2 and how much comes from your dual platform. That is the reason why we have chosen two weeks dual lead-in and then add the third component so that we have a comparison as well, dual versus triple, and how good the dual platform is and how much the C2 adds to it.
Homozygous, heterozygotes, that more has to do then as a consequence of the dual lead-in, where in fact for the heterozygotes, you don't expect too much of efficacy. That's why we said, okay, putting the heterozygous patients on the two-week lead-in is something which, okay, there is zero benefit from them expected, and that's why we have limited that to one part of the study only. That is the reason. Thank you.
Great. One last follow-up question on CF. On the PELICAN trial, I think in the answer to a previous question, you said if the levels of 2737 that are achieved are sufficient, you expect to see good data. I'm just curious, in your mind, what would be a good additive impact on FEV1 on top of ORKAMBI?
Thank you. I think in the previous call I said something around 5% of additional FEV1, and that's the threshold that we hope to achieve. Let's stay with that number.
Fair enough. Thanks for taking my questions.
Thank you.
We will now take our next question from Christopher Murray from Nomura. Please go ahead.
Good morning. Thank you for taking the questions. Just first on FINCH 2, with top-line data expected mid-year. I was wondering if you could comment if you will be releasing any data beyond the primary or beyond the ACR20, any ACR50/70 at 12 weeks. Perhaps could you comment on any of the safety that you've seen in the ongoing trials of filgotinib, maybe talk about any DVT or any other signals that may have popped up. Thank you.
Okay, I guess this one is for me, Walid. Thanks, Chris, for the question. With regard to the top line for FINCH 2, this is something that we have to discuss with our partner right now. We don't have a clear visibility exactly today that we can share with you about what we will be sharing. We have to keep in mind also certain conditions that would later not be detrimental to us publishing these data and showing them at major conferences. There are obviously some important information that we will have to share because they are important for our company from a material perspective. Turning to your other question on the safety, of course, this is a heightened issue in people's mind after the outcome also recently. We will be presenting data from our ongoing open label study, DARWIN 3 at EULAR.
That would be week 108, approximately more than two years, actually, at this point, open label data. I don't want to steal the thunder from that, but we're quite comfortable with the data that is coming to date and we'll be sharing this. I think our DVT and thromboembolic events rate is still in the low level of around 0.1 event per 100 patient-year , which we're actually quite pleased with so far.
Okay, great. Just maybe one more on ISABELA. Could you maybe comment on the recruitment across geographies for that trial and the expectation for standard of care use across geographies? Maybe comment on any interim analysis that you may be doing, futility analysis, when those might occur. If you're doing a sample size readjustment at any time point in that trial. Thank you.
Thanks, Chris. Geographies, we're going to be going global, U.S., big EU, and also Australia, around the world, honestly. We have to be very careful with the patients that we get in. We have to make sure that the composition of our patients would reflect the standard of care that we see in the U.S. and the big EU 5. That's important because if we are going on top of standard of care, we need to make sure that the standard of care that these patients are receiving are similar to standard of care for the U.S. and the European countries, so that we can be able to extrapolate to that patient group. With regard to a futility analysis, yes, indeed. I think it's important for us.
As much as we are confident in our data from the FLORA study, it still is a smaller study of a shorter duration, and now we're taking a big leap into a robust phase III program, 1,500 patients total for at least one year duration in this program. It's important for us to include a futility analysis in the event that we're making the wrong call and the data from FLORA were a fluke, so to speak. We will be conducting this. We haven't yet precisely nailed the number of patients we need to have before we do it.
Currently, our thinking is when we have about a quarter of the patients enrolled and gone through one year of treatment, we'll do a futility analysis, which will allow us to decide whether we should stop if we have a futility across both doses or continue with the trial if at least one dose is not futile. That's the current plan. We do not have any plans to do sample size re-estimation based on variability. We were fortunate that there's a large database in nintedanib and pirfenidone to give you a sense from their placebo arm, but also from the treatment arm, about the magnitude of the variability and the standard deviation. We've used that pool standard deviation, specifically it's 270 mils, if you guys are interested, to be able to draw our sample size based on that.
Great. Very helpful. Thank you.
We will now take our next question from Matthew Harrison from Morgan Stanley. Please go ahead.
Hi, this is Vikram on for Matthew. We had a question on MOR106. Could you just update us on the sub-Q formulation work you're doing? If you could let us know if the study that's being conducted later in 2018, is that going to be using the sub-Q formulation or not? Thanks.
Okay, Piet here. I'll take the question on MOR106. MOR106, we plan a couple of studies this year. The first study that will kick off and where we hope over the coming weeks to have first patient in. At that moment, we will announce as well the design. It's a dose range of phase II study, where we have five dosages and placebo. This will be an IV study. In parallel to this phase II study, we will start a first-in-human with the sub-Q as well this year. The idea is that sub-Q study will both run as a single dose in healthy volunteers, but as well a multiple dose in patients. Then the idea is to bridge the sub-Q data from the patients with the IV data of the dose ranging to select sub-Q doses for further development.
We'll run both sub-Q and IV studies this year. That's the short answer.
Okay, thanks.
As a reminder, if you would like to ask a question, please press star one. We'll now take our next question from Katherine Tsai from William Blair. Please go ahead.
Yeah, good morning. I'm just wondering with regards to the cystic fibrosis program, can you provide some color on why the delay in the U.K. on the start of the Triple FALCON study? Does that impact the strategy on the rest two triples? Are they on track? If you could provide timelines on those, that'll be very helpful. Thank you.
The question's sort of been difficult to understand. I'm assuming the first question was on the approval time for the FALCON study.
Yes.
Yeah. Over recent years, I think we've shown that typically we are quite reasonably good in our estimates of starting up timelines. FALCON fall a bit outside those estimations. I can't point to any specific reason. We've been in contact with the principal investigators in the U.K. He's been to the ethical committee as well. In fact, if you see what type of questions we did receive, they were more standard questions that we could answer quickly. For one or another reason, and we don't know why, the formal procedure to get a signed approval took a bit longer than we normally had. You were questioning on timelines for the other triples. The PELICAN study, that is on track. We will report out Q2. We plan as well to start up another triple study, GLPG3067 as a potentiator.
This will be a bigger study with those ranging components of both GLPG3067 and GLPG2737. We are on plan there. We've announced that we've completed the phase I package for the triple, both SAD and MAD in healthy volunteers. We've been discussing those data with the authorities and will file soon the paper trials application as was planned previously. Those dates are what we have been given before. Thank you very much.
Thank you.
It appears there are no further questions, so I'd like to hand back the call to the speakers for any additional or closing remarks.
Thank you all for your participation today. I just want you to note that our next planned financial results webcast is on August 3rd, with publication of results the night before. Please mark that in your calendars. Thanks again to all the callers for the support and participation, and thank you and goodbye.