Galapagos - Earnings Call - Q1 2018
April 26, 2018
Transcript
Speaker 0
Good day, and welcome to the Galapagos Quarter One 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.
Speaker 1
Thank you and 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 Elapagos website homepage and will be available for replay later on today. So 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, Two Four Zero Four Zero Six Five Nine and 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. So today's participants will be Ana Van Stolpe, CEO Walid Abhisab, CMO Pete Wiechrenk, CSO and Bart Filius, COO and CFO.
We will begin with some PowerPoint slides followed by a Q and A session. And with that, I'd like to hand over to Anno. Go ahead, Anno.
Speaker 2
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 and A. So I'll jump right in with the first slide about the delivery in the first quarter twenty eighteen. 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 nine thousand seventy two. 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, and 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. And we also completed the recruitment of the PELECON study, which is the combination of our C2 with ORKAMBI. And then finally, we got approval for the FALCON first triple combo trial. So 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 €1,100,000,000 by the end of the quarter.
So let's start with the Phase III program, ISABELA for 1690, our IPF program. We will conduct two Phase III programs for a total of 1,500 patients. And all these patients will remain on standard of care throughout the trial, and they will stay on drug throughout the whole Phase III program until the last patient has been dosed. There
Speaker 3
will
Speaker 2
be two doses just tested. It's a fifty two 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's yes, 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 we move to cystic fibrosis, the Falcon study is 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, and 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 triple dosing, both of them for two weeks. And we'll start with a first dose in homozygous patients, Delta-five zero eight, and then followed by a second higher dose, where we'll dose both in heterozygous as well as homozygous patients. Small cohorts, short dosing, but 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, but also very important to look at the efficacy levels in this trial. If you look out for the rest of the year, then 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. And a number of those trials will take quite a long time to recruit and, of course, administer the drug. So they will run for a long time. But 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 PELECON cystic fibrosis study. Also important, we'll get the gono go with regard to filgotinib in ulcerative colitis, if it will move from the Phase into Phase three. We will not release data on that. It will just be an announcement that this trial has moved from a Phase two to a Phase three. And we're expecting very shortly the full enrollment for FINCH one and FINCH three, greatly ahead of the original scheduled timing.
For the next half year, so after this quarter, very importantly, the first Phase three trial will read out the FINCH two trial in 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. And with that, I'm happy to hand it over to our CFO, Mike.
Speaker 3
Thanks, Arnaud, and good morning, everyone, in The U. S, and good afternoon in Europe. Happy to give you the view on the Q1 financials as well. And 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. And we've closed up the quarter with a cash balance of €1,100,000,000 down from €1,150,000,000 at the December.
Our net cash burn in our definition was €40,000,000 for that quarter, consisting on one hand of cash out, cash expenses of roughly €60,000,000 and on the other hand, cash income from milestones of a little less than 20,000,000 So we've maintained our guidance obviously in the first quarter. We're early on in the year between $220,000,000 and $240,000,000 for the full year. So we're below let's say, the 25% mark after the first quarter. That's really due to two reasons. One hand, obviously, as you can see, the offsets of cash income from milestones.
And on the other hand, the expenses will be gearing up towards the later parts of the year when the Isabella program will go online in full in the second half. Two other elements that have influenced our cash position to a lesser extent, bit from capital increases. Those are related to warrant exercises. And 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. Then on the next slide, I'm summarizing the key other components of our P and L.
Also as Ono was doing in a shortened version compared to what we've done in the past, so I'll take you through the P and L on this slide with the highlights thereon. Revenues are up by €5,000,000 to €45,000,000 That includes roughly €10,000,000 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. And we are recognizing roughly €10,000,000 in this quarter, and this will influence our top line positively for the next eight quarters, so until, let's say, the 2019 is our estimation by roughly this amount to total roughly €80,000,000 of re recognition under IFRS 15. So 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 €77,000,000 and they are higher by roughly €25,000,000 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. And then finally, net results, down by €24,000,000 mainly driven by the operating costs, but also this unrealized currency translation effect has a negative on our P and L, even though obviously this is not fully materialized until you expense it.
So 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. And with this, I'll hand it actually back over to Elizabeth to take us through the Q and A, for which Onno and I are available, but also Valid and Pete are available for taking any of your questions.
Speaker 1
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.
Speaker 0
Thank We'll take our first question from Anastasia Karpova from Kepler. Please go ahead. Your line is open.
Speaker 4
Hi. Two clarifying questions on the upcoming readouts. Mechanistically speaking, would you expect to have dramatically different efficacy in psoriatic arthritis compared to what SOFA has shown due to lack of JAK3 inhibition? And for the second, can you help me understand how aggressive is the futility threshold in the upcoming ulcerative colitis trial? Is that something very challenging ahead of available therapies or something more conservative?
Thanks.
Speaker 5
Okay. This is Walid. I guess I'll take both questions. So first, let me start with the futility analysis. So the point there is to compare each dose of filgotinib to see whether it's performing worse than placebo.
And if that's the case, you would meet futility. So essentially, the point is that the threshold is really not very high. So in other words, it's very unlikely that we will be meeting that futility analysis, but that's an important test that we needed to do. On your other question regarding mechanistically whether we see 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 nonselective hitting other JAKs. So we're quite hopeful that we will have efficacy better than TOFA.
Speaker 4
Thanks a lot.
Speaker 0
We will now take our next question from Peter Welford from Jefferies. Please go ahead.
Speaker 6
Hi, yes. Thanks for taking my questions. Got a couple really on the upcoming planned trials. And 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? And then 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?
Or is that just a different dose of the early stage corrector that's going to be used in that FTC? Then in a similar vein for the IPF sixteen ninety Phase III Isabella trial, I presume that one of the doses either A or B will be the dose that was used in the Phase IIa trial. But can you give us some insights into what the other dose that was chosen will be? And will that dose be the same in both of the Phase 3s? Or will one Phase three 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.
Speaker 7
Okay. Pete here. I will start with the question on the FALCON DESIGN. So FALCON design is the first CF study in which we'll dose our fully owned our fully homemade triple combo in CF patients. So 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.
So indeed in this study on day one, the patients will get a lowering dose of potentiated 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. So 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. I'll hand it over to you for IPF then.
Speaker 5
Okay. Thanks, Pete. So the ISEVELLA 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 two study, but we're not disclosing at this point what is the other dose, which obviously is a lower dose in that trial.
So in terms of feedback, these the design of the study, including the dose selection was discussed with both the FDA and EMA. And there was full support for our proposal. And based on that, we confirm the trial that we moved forward with.
Speaker 6
That's great. Thank you. I'll jump back in.
Speaker 0
We will now take our next question from Brian Abraham from RBC Capital Markets. Please go ahead.
Speaker 8
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 ISBELA 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 esbiotorofev?
Speaker 5
Okay. So you want me to answer this and then you will ask the CF question, Brian?
Speaker 6
Yes.
Speaker 5
Okay. All right. We looked at, I mean, so 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. But 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 placebo controlled trial. This has been an issue that's been very clear to us when we talk to the KOLs, when we talk to the Pulmonary Fibrosis Foundation, which is obviously we work very closely with, and also when we talk to regulators. So as a result, we decided to design a study to go on top of standard of care. Now the way the standard of care is, and and we mostly have that information from The US where the Pulmonary Fibrosis Foundation has a good assessment of the situation, we know that about a third of the patients are on propranolone, about a third roughly are on nintedinib, and a third are on neither, propranolone or nintedinib. And that is a representative sample of The US population, which is gonna be forming the basis of how we're gonna be doing our trial.
So essentially, in our trials, will we will make sure that we keep people on whatever background medicine they're on. If they're on neither, they they can stay on neither and come into our trial. We will not be dictating any changes in their background therapy. But we make sure that we are adequately stratified because we don't want certain groups to be overrepresented in one dose group or the other. So 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 health authorities as well. And 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. So anything in the thirty, forty ml over a year is very weak. Just to put it in perspective, the current treatments with mantadenomic methionine, have a reduction of about maybe one hundred and twenty ml to one hundred and fifty ml after a year. So essentially there's still room to grow, but anything less than sizable about 80 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. And this is what we use as a guide to power our studies. So our studies are powered to detect with 90% power, which is typical of Phase III to detect an eighty ml difference from background of treatment. And that's kind of what we proposed and the health authorities supported us with this.
Speaker 8
That's really helpful color. And 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 one to be the therapeutic doses and maybe what you would see as an FEV1 bar for that Part one? And then perhaps how the results of the upcoming PELICAN readout would influence your dose selection plan for two thousand seven hundred thirty seven in the second two weeks when it gets added on? And I'll hop back in the queue.
Thanks.
Speaker 7
Okay. Brian, I'll try to answer because you broke up for a moment while asking your question. So the FALCON study, so Part one, we should be at around EC80, EC90 level with the first dose. So we really should see efficacy. It's clear that the dose of two thousand two hundred and twenty two is informed with what we've done a benign patient and which is well known to all of you.
And so for that part, a, in fact, the only unknown there is whether our assessment of active dose of potentiators, two thousand four hundred fifty one is right, but we've chosen a dose which should clearly give us a good signal in that population. PELECAN upcoming data, in principle, we don't need those data for FARCON study to start. It's a study where we dose two thousand seven hundred thirty seven on top of ORKAMBI. There, of course, the unknown is how big will be the impact of LUMA catheter in terms of PK interaction of two thousand seven hundred thirty seven as well there based on study results on DDI study with rifampin, we hope to be up around EC19 for two thousand seven hundred thirty seven, but the big unknown will be on how accurate the rifampin data will predict the exposures we will observe then with two thousand seven hundred thirty seven. So if the exposure of two thousand hundred thirty seven 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.
Speaker 6
Thank you.
Speaker 0
We will now take our next question from Adam Walsh from Stifel. Please go ahead.
Speaker 9
Good morning. Thanks for taking my question. I guess this one is 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.
So with respect to filgotinib dosing in the ongoing 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?
Speaker 5
Thank you, Adam. If you recall in the filgotinib program, we did a dose range finding And based on these data, the doses of one hundred and two hundred milligrams were selected. Those doses were reviewed and discussed with the agency at the time as part of the end of Phase two meeting and 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.
And 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 IVD program where we set fully one hundred and two hundred 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.
Speaker 9
Hey, that's helpful. And then just one follow-up if I could on the ISEVELLA Phase III program in IPF. Can you just give us a rough idea when we might see first data from those trials?
Speaker 5
Yes, it's a tough question, Brian. At this point, I don't feel comfortable guiding on the time. And for the simple reason is that there's no good way to estimate it. So now when we do our feasibility and talk to a number of people, they come back with some numbers based on their experience with pifedanone and entendenib in the past. But 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 nipenematifenidone were conducted, the Phase three programs. And number two, in our case, we are going on top of standard of care, whether you are on nipenematifenidone or you are not. And 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.
Speaker 9
Fair enough. Thank you.
Speaker 0
We will now take our next question from Vamil Divan from Credit Suisse. Please go ahead.
Speaker 10
Hi, great. Thanks so much for taking my question and thanks for the efficient call today. I appreciate it on a busy day. So just two things, one on the filgotinib side and then one on CF. So on filgotinib, if you could just provide an update on the long term safety study and timing around when those results would be available?
And just to confirm because we've got some questions that that is a requirement before you can submit the filing to the FDA or not, if you can confirm that. And then on going back to CF and the FALCON study just with 02/1951, 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? So
Speaker 5
may I ask a clarifying question? This is Walid. You said long term safety?
Speaker 10
The male trial.
Speaker 5
Right. So the male safety trial is ongoing as we talked about, as we've discussed previously. And we believe that we will have the right data set by the time we are ready to file to be able to have a total package that would satisfy the FDA's requirement.
Speaker 7
Okay. Thanks. I'll comment then on the SOMESCF question. Well, this which is in the FARCAN study, which is the first time we dosed two thousand four hundred fifty one in Phase II, It's logic that we want to follow-up both safety and efficacy of two thousand four hundred fifty one as long as the compound is around. So what is foreseen in the protocol is that we that the patients will be invited to come to the center as long as we detect the long living metabolite.
And so the expectation that we have a couple of months that will disappear, but that's what is foreseen currently that we monitor the metabolite up to the moment where it disappears. Thank you very much.
Speaker 0
We will now take our next question from Phil Nadeau from Cowen and Co. Please go ahead.
Speaker 11
Good morning. Thanks for taking my questions and congratulations on the progress. Just a couple on the design of the FALCON study. Was curious about a couple of things. First was on the two week lead in with the dual therapy.
What's the rationale behind that? Is that to show the additive efficacy of the C2? Or is that to get the dual therapies up to stay state levels before adding the C2? That's the first question. Then the second question is, in Part A, why are you looking at only homozygous patients, not include heterozygous patients, Hetmin patients in Part A as well or Part one, sorry.
Speaker 7
Okay. Thank you for the question on FALCON. So the two week lead in JUUL 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 JUUL therapy. If you would start with the triple therapy immediately, then whatever you can measure in terms of improvement at the end is a sum of the three and you it's impossible then to distinguish how much comes from the C2 and how much comes from your dual platform. So that is that's reason why we've chosen two weeks dual lead in and then at the third component, so that we have a competitor as well dual versus triple and what how good the dual platform is and how much the C2 adds to it.
Homozygous hit heterozygous that more has to do then as a consequence of the dual lead in, where in fact for the heterozygous, you don't expect too much of efficacy. So that's why we said, okay, putting the heterozygous patients on the two week ligands 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 as the reason. Thank you.
Speaker 11
Great. And then one last follow-up question on CF. On the PELICAN trial, I think in the answer to a previous question, said if the levels of 2,737 that are achieved are sufficient, you expect to see good data. I'm just curious in your mind, would be a good additive impact on FEV1 on top of ORKAMBI?
Speaker 7
Thank you. So I think in the previous call, said something around five percent of additional EVV and that's the threshold that we hope to achieve. And so let's stay with that number.
Speaker 11
Fair enough. Thanks for taking my questions.
Speaker 7
Thank you.
Speaker 0
We will now take our next question from Christopher Marai from Nomura. Please go ahead.
Speaker 12
Good morning. Thank you for taking the questions. Just first on FINCH two with top line data expected sort of 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, seventy twelve weeks? At And then 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.
Speaker 5
Okay. I guess this one is for me. Tawade, thanks Chris for the questions. So with regard to the top line for FINCH two, 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 about that would later not be detrimental to us being publishing these data and showing them at major conferences. But 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, with this is a heightened issue in people's mind after the outcome also recently. So we will be presenting data from our ongoing open label study DARWIN-three at Tulare, so that would be week 108, so approximately more than two years actually at this point open label data. So 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.
But I think DVT and or thromboembolic events rate is still in the low level of around zero point one event per 100 patient here, which we were actually quite pleased with so far.
Speaker 12
Okay, great. And then just maybe one more on Isabella. Could you maybe comment on the recruitment across geographies for that trial and the expectation for standard of care use across geographies? And then maybe comment on any interim analysis that you may be doing futility analysis when those might occur? And if you're doing a sample size readjustment at any time point in that trial?
Thank you.
Speaker 5
Thanks, Chris. So geographies, we're going to be going global, U. S, big EU and also Australia around the world honestly. But 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 U.
S. And the big EU5. 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 US and the European countries so that we can be able to extrapolate to that patient group. With regard to 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 three program, 1,500 patients total for at least one year duration in this program.
So it's important for us to include the futility analysis in the event that we're making the wrong call and the data from FLORA are actually were a fluke, so to speak. So we will be conducting this. We haven't yet precisely nailed the number of patients we need to have before we do it. But currently our thinking is when we have about a quarter of the patients enrolled and gone through one year of treatment, we will take a futility analysis, which will allow us to decide whether we should stop if we have 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've used the totality of the data from the were fortunate that there's a large database in lintadenib and trefrenidone 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 and we've used that pool standard deviation specifically it's two seventy mils. If you guys are interested to be able to draw our sample size based on that.
Speaker 12
Great. Very helpful. Thank you.
Speaker 0
We will now take our next question from Matthew Harrison from Morgan Stanley. Please go ahead.
Speaker 13
Hi, this is Vikram on for Matthew. So we had a question on MOR106. Could you just update us on the subcu formulation work you're doing? And if you could let us know if the study that's being conducted later in 2018, is that going to be using the subcu formulation or not? Thanks.
Speaker 7
Okay. Pete here. I'll take the question on So MOR106, plan a couple of studies this year. So the first study that will kick off and where we hope over the coming weeks to have first patient in that moment, we will announce as well the design is a dose range of Phase two study, where we have five dosages and placebo, but this will be an IV study. And so in parallel to this Phase two study, we will start first into human with the subcu as well this year.
And so the idea is that subcu study will both run as a single dose in healthy volunteers, but as well a multiple dose in patients. And then we'll the idea is to bridge the subcu data from the patients with the IV data of the Dose Ranger to select subcu doses for further development. So we'll run both subcu and IV studies this year. That's the short answer.
Speaker 5
Okay. Thanks.
Speaker 0
We'll now take our next question from Catherine Zhou from William Blair. Please go ahead.
Speaker 1
Yes, good morning. I'm just wondering with regards to the cystic fibrosis program, can you provide some color on why the delay in UK on the start of the triple FALCON study? And then does that impact the strategy on the rest two triples? Are they on track? And then if you could provide timelines on those, that would be helpful.
Thank you.
Speaker 7
So question is a little bit difficult to understand. So I'm assuming the first question was on the approval time for the FALCON study. So yes, so over recent years, I think we've shown that typically we are quite reasonably good in our estimates of starting up time lines. Falcon fall a bit outside those estimations. So but there was, in fact, no I can't point to any specific reason.
We've been in contact with the principal investigators in The UK. He's been to the ethical committee as well. And we in fact, if you see what type of questions we did receive, there was more standard questions that we could answer quickly. But for one or another reason, we don't know why the formal procedure to get a signed approval took bit longer than we normally had. And then you were questioning on timelines for the other triples.
So the Pelican study, that is on track. So we will report out Q2. Then we plan as well to start up another triple study, 3067 is a potentiator. So this will be a bigger study with those ranging components of both three thousand six hundred seventy seven and two thousand seven hundred thirty seven. So we are on plan there.
So we've announced that we've completed the Phase one package for the triple both SED and Amelin in healthy volunteers. And we've been discussing those data with the authorities and we'll file soon the clinical trials application as was planned previously so and those dates are what we have been given before. Thank you very much.
Speaker 5
Thank you.
Speaker 0
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.
Speaker 1
Thank you all for your participation today. I just want you to note that our next planned financial results webcast is on August 3 with publication of results the night before. So please mark that in your calendars. Thanks again to all the callers for the support and participation. And thank you and goodbye.