DBV Technologies SA at Bank of America Merrill Lynch Health Care Conference

May 11, 2016 AM EDT
DBV.PA - DBV Technologies SA
DBV Technologies SA at Bank of America Merrill Lynch Health Care Conference
May 11, 2016 / 10:40PM GMT 

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Corporate Participants
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   *  Pierre-Henri Benhamou
      DBV Technologies SA - Chairman and CEO
   *  David Schilansky
      DBV Technologies SA - COO
   *  Susanna Mesa
      DBV Technologies SA - VP, Finance, US IR & Strategy

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Conference Call Participants
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   *  Tazeen Ahmad
      BofA Merrill Lynch - Analyst

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Presentation
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 Tazeen Ahmad,  BofA Merrill Lynch - Analyst   [1]
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 Good afternoon. I am Tazeen Ahmad. I am the smid-cap biotech analyst here at Bank of America Merrill Lynch. It's my pleasure this afternoon to introduce our next presenting Company, DBV Technologies.

 At the stage is -- at the stage this afternoon and sitting next to me is the DBV Management team. Sitting directly next to me is David Schilansky, is the Chief Operating Officer. Sitting next to him is Susanna Mesa, who is the world's best IR person. And at the podium is Pierre-Henri Benhamou, who is President and CEO of the Company.

 So, we'll start off by giving you a short slide presentation of the basics of DBV, and then we'll switch over to fireside chat format. And if anybody has questions from the audience, just please raise your hand and let us know, and we'll bring you a mic. And with that, we'll turn the podium over to Pierre-Henri.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman and CEO   [2]
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 Hello, everybody. Thank you very much. It's a very nice place for a conference. And I just -- we didn't want to show you all the presentation here, but just to make a very quick introduction, and then to answer all the question. Because I think some of you know what we are doing.

 We -- so, as you know, we are a Company developing a new method for the treatment of food allergy, and our first treatment is about peanut allergy. And the way of -- we have developed this treatment is really to find a new way of administration in -- to allow the patient to have the safest treatment possible for the treatment of peanut allergy.

 As you know, it's a very dangerous allergy, and many treatment already proposed have this big issue in the safety point of view. So, the treatment we have developed is -- has three main advantages. First is the safety. There is -- in all the studies we have already performed, safety is perfect, and there is no need of epinephrine or rescue medication during the treatment.

 The second point is compliance. Every -- in every studies, especially in the two last studies we have performed, the first is the -- our Phase II studies, the VIPES study; and the second is a study founded by the NIH, via the CoFAR, which is the Consortium of Food Allergy Research, recently published at the AAAAI meeting. And in these two studies, the compliance rate is very, very high. More than 95% of the patch has been used by the patient during the treatment.

 And the third advantage is the efficacy. And especially for the children, the efficacy of the product is very interesting, because the very allergic patient, very reactive patient, are with treatment in safest position, even after only one year of the treatment.

 The Company has been founded in Paris, in France, but it's -- the main development in the -- is in the US. And also, our main investors -- more than 80% of the capital -- is now American. And we are listed in the NASDAQ, and we have recently made follow-on funding of $280 million in -- for us, it was a double good news, because it was very nice fundraising, and also it was July 14, which is the national fest for French people.

 The development of the patch, we have developed with a very specific technology and fully patented technology, is for peanut first, and we are in Phase III -- in the middle of the Phase III, with a breakthrough designation. And the second product is the milk, and we are in the middle of the recruitment phase of Phase II for the milk Viaskin. Viaskin is the name of the product.

 So, in all the study we have performed, the primary endpoint have been met, and the profile of the safety was really impressive. We think we will be able to complete recruitment of the large Phase III. It's 330 patients, only children, in the -- in Q3 2016. And we will be able to complete this study in one year later, in order to be able to file as a -- to file to the FDA at the beginning of 2018.

 So, this is all the main data concerning the Company. And there is one thing more. We -- our intention is to commercialize by ourselves the product, especially in the US. We are starting to move in Europe too. But the first market is obviously -- for peanut allergy, is US. And it will be the first target for the Company. So, we are developing a large US Company now, with many people involved in realizing the launch of the product.

 So, this is -- now we can have answer to your question with great pleasure.

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Questions and Answers
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 Tazeen Ahmad,  BofA Merrill Lynch - Analyst   [1]
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 Thank you for the presentation. Maybe, Pierre-Henri, can you give us a summary of your Phase II data from the VIPES, including the 2-year update, and maybe talk to differences in your Phase III trial that's going to be completing next year versus what you showed in Phase II, and why you made certain changes to the trial design. And then if David has anything to add to that as well.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman and CEO   [2]
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 Okay. For the Phase II, the Phase II has been published last year, in last -- no, 2 years ago, for the results of 1 year of treatment. And then we had -- excuse me, I'm just going to the Phase II. And we were able to publish the 2 years of treatment results at the AAAAI, which is the largest meeting of allergy in the world.

 And the protocol of all the study is always the same. Patient are evaluated at the beginning by a double-blind placebo challenge -- food challenge, at the beginning. We see by increasing dose of allergen, at what level the patient is reacting. And then we introduce the treatment, and the patient is evaluated 1 year later, after the beginning of the treatment.

 And we consider that the treatment is a success when the patient is able to multiply by at least 10 the amount of allergen he is able to take during the challenge.

 The main results concern the level of, of course, the safety, and the level of the compliance, and -- 97% in this study. And also the dropout rate, which is really, really low, because only two patients in this study stopped the treatment because they had some redness under the patch.

 And the results -- of course, the primary endpoint were met and -- but the results were more interesting in children, with a big difference especially for the highest dose at 250 micrograms in the patch. And when you see the cumulative dose the patient were able to take during the treatment, it was very interesting, because in the mean they were able to take four to five peanut. These patient were not able to take more than 1/10 of peanut in median at the beginning of the treatment.

 And what is interesting now is that we have the results of the 2 years of treatment. As you can see, in children the level of success after 1 year was 57% of success, and after 2 years, 80% of success. And in the right part of the slide, you can see also the increase of the cumulative dose that patient were able to take during the challenge. And it increases by the years after years, which is a very good thing.

 And the level of tolerance we can induce by the treatment is very important -- 1.4 grams of peanut protein, which is roughly six peanuts, for this patient not able to take 1/10 of peanut at the beginning of the treatment.

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 David Schilansky,  DBV Technologies SA - COO   [3]
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 So, we've entered into a Phase III. The first patient was included in December last year. The age range is 4 to 11 years old. And we will be expanding the age range as we go.

 We also intend to start a Phase III trial in the 1-, 2-, and 3-year-olds, which are the younger patients, by the end of this year; and also target the adults and adolescents, for which we didn't achieve statistical significance, but we intend to use a higher dose of Viaskin Peanut and launch this trial in the year or 2 years to come.

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 Susanna Mesa,  DBV Technologies SA - VP, Finance, US IR & Strategy   [4]
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 And I think I'll just add to what you asked, is that what's very nice about our data is that not only do we have the Phase II data -- that we've seen the clinical efficacy as well as the safety -- but we do have three other trials including a Phase I and two independently-performed trials, one by the NIH and another one by a similar institution in France, and we continue to see that same efficacy trend that we see in our Phase II, as well as the same safety and compliance that we see in our Phase II. So, as we get closer to the Phase III, we get more comfortable in thinking that our data fits into what we're trying to do.

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 Tazeen Ahmad,  BofA Merrill Lynch - Analyst   [5]
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 Okay. Thanks for the color. And then maybe can you talk to -- there -- I think there might be some misperceptions of what the discontinuation rate was from the first year of VIPES heading into the second year. Can you talk to how many patients actually dropped out of the trial, versus chose not to continue? I think there's a bit of a difference there.

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 David Schilansky,  DBV Technologies SA - COO   [6]
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 Yes. I think maybe it's on slide 18. But it's true that there is -- technically, the second year is a new trial, so you need to renew the consent to the patients and they need to opt in. So, they had the choice not to do the second year.

 In the first year of treatment the dropout, as Pierre-Henri just explained, was 6% overall in the entire population, and less than 1%, which are -- which were two patients linked to Viaskin.

 And at the end of the treatment, we had an 83% rollover rate of patients choosing to go into the second year. 7% of children decided not to go into the second year. Many different reasons. It can be satisfying food challenges. It can be that they are moving somewhere else.

 And adolescents and -- we also obviously -- as you can see here, we saw higher non-rollover rate of adolescents and adults, and we can assume that since the Company communicated on a non-statistically significant efficacy, some adolescents and adults decided not to pursue treatment.

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 Susanna Mesa,  DBV Technologies SA - VP, Finance, US IR & Strategy   [7]
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 But I think that's a great question. We really do have to differentiate between the opt-in and rollover. It's two completely different things. And dropout, of course, yes. And at the end of the day, what we're seeing is that some of the patients actually that went through that first year of therapy and decided not to roll over, was maybe because we're getting to such high levels in the food challenge that they actually decided to possibly introduce peanut to their diet, with their physician taking them that route. So, it -- again, it's not the same thing when we're thinking apples to apples.

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 Tazeen Ahmad,  BofA Merrill Lynch - Analyst   [8]
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 And then maybe to put it into context, at what dose of peanut antigen do most people who are allergic to peanuts have a sensitive reaction? So, Pierre-Henri mentioned that at the end of the trial there were some patients that were able to take -- to have exposure to six peanuts without having a reaction, when in the beginning of the trial they could barely tolerate 1/10 of a peanut. So, in the real-world setting, what can set off an allergic reaction to peanuts? How much of a peanut can do that?

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman and CEO   [9]
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 David?

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 David Schilansky,  DBV Technologies SA - COO   [10]
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 I think what we've -- what the data says is that most accidental exposure occur at around 40 milligram to 60 milligram, despite a very strict diet, which is typically the kind of -- which is 1/5 or 1/6 of a peanut, which is typically the kind of amount that you cannot see in a meal.

 And the data that we've shown at the congress in March -- we've carried out a study with the University of Nebraska -- showed that if you can bring these patients that have an accidental exposure to tiny amounts -- 40 milligrams, 50 milligrams, to more than 300 milligrams -- then you de-risk in their real life. It was a real-life study on hundreds and thousands of exposure. You can de-risk, and basically lower their risk of a violent reaction by 99.5%. So, in the real life, it's really about lowering the risk of a patient, giving his initial sensitivity, so to speak.

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 Tazeen Ahmad,  BofA Merrill Lynch - Analyst   [11]
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 So, in your discussions with FDA, is that a point that's clear to them -- that your therapy is not meant to cure people of peanut allergy but just to increase their tolerance level to peanuts? And is that going to be sufficient enough for FDA to approve a therapy like yours?

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman and CEO   [12]
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 Of course, we have extensively discussed with the authorities on the endpoints and what we are expecting from the treatments. And it's clear that when you have a very reactive patient, what you want, really, is to put this patient at major risk of anaphylaxis, at every moment in a safe zone.

 And we have proved in the frame of collaboration with Nebraska University that if you react at 10 milligrams -- 10 milligrams, one peanut -- 300s, (inaudible) to remind you -- and when you are at 10 milligrams at baseline and you go to 300 milligrams -- one peanut -- after one year, you reduce the risk of anaphylaxis in case of accidental exposure to peanut -- you decrease this risk by 99.5%. Which is meaningful for the very reactive patients.

 And for the other, a bit less reactive -- reactive at 1/10 of peanut, for example, 30 milligrams, 100 milligram, or 300 milligram, you consider that if you can put them at 1 gram, it's also very meaningful, because you are putting them in the safe zone.

 And this is what we have negotiated with the European and US and FDA, and this is what we will see with our Phase III study. But, of course, we have used the data we had from the different studies and we saw that, even with a small number of patients, it works perfectly, and the difference between the placebo group and the active group is of course very significant.

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 Susanna Mesa,  DBV Technologies SA - VP, Finance, US IR & Strategy   [13]
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 And I think it's important to remember that our regulatory pathway is something that we've been working for the last 5 years. We had a robust Phase I in all populations. We had a -- one of the largest Phase IIb conducted in the clinical setting in peanut allergy. And we've built the regulatory pathway for food allergies. We've done that in conjunction with the FDA. We received breakthrough therapy.

 And I think we were very satisfied to see that all of the regulatory endpoints, as well as the efficacy evaluation, safety evaluation -- all of the things that we've been discussing with the FDA for the last 5 years -- all of those points were emphasized by them during the recent Ad Comm panel in January.

 Everything from the endpoint until -- through the necessity of a safe product -- all those things were emphasized. So, we feel very comfortable with that -- what we're doing is -- it fits within what the FDA would want to see.

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 David Schilansky,  DBV Technologies SA - COO   [14]
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 And we've been breaking grounds with the FDA on every front. I mean, we've been discussing first with the FDA for the past 5 years, so we've fine-tuned everything; we've refined everything.

 But the level of confidence today we have is as good as it can be. I mean, we have discussed these endpoints with the FDA for probably 6 months. And we've obtained clarification. Now, it's never 100% for sure, but it's as good as it can be, for sure.

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 Tazeen Ahmad,  BofA Merrill Lynch - Analyst   [15]
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 And then, can you just remind us of how many patients have been exposed to the patch since you started clinical trials?

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman and CEO   [16]
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 Susanna, I think you are the only person able to answer this question.

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 David Schilansky,  DBV Technologies SA - COO   [17]
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 Sure.

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 Susanna Mesa,  DBV Technologies SA - VP, Finance, US IR & Strategy   [18]
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 I think for Viaskin Peanut we've had a little bit over 450. And again, what we feel very proud of is that we can continue to say that, out of those 450, not one single patient has ever had an SAE that's related to treatment, or even an epinephrine that is associated with treatment.

 So, from our perspective, that is -- in itself is a unique and completely different type of approach to food allergies. And nobody [else] can claim a profile like that in terms of tolerability.

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 Tazeen Ahmad,  BofA Merrill Lynch - Analyst   [19]
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 Okay. I do have more questions, but I just want to make sure, are there any more questions on the floor? Okay. So, recently, you were at the AAAAI conference, and you have the benefit of a government-sponsored trial called CoFAR, independently validating the data that you had collected in your Phase II trial. Can you talk about that trial specifically, and what the importance of that trial mimicking the results that you had obtained in VIPES really means?

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman and CEO   [20]
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 It was very important for us, but very risky also, because it's not comfortable when you are aren't able to see any result -- any information. And the NIH-sponsored study are very, very closed, and not very open to the company who collaborate with these institutions. So, we were completely blind at the moment of the publication of the results, and you can think that we were a bit in better shape after the results than before.

 And what we saw -- it's that there is -- the results are clearly exactly the same than the one we had published in our own study. And, of course, the -- we reached the endpoint, and even with a higher number than the -- in VIPES study, and it was very interesting to see the magnitude of this efficacy.

 One-third of the patient were able to tolerate 1 gram, which is a very good level of efficacy, because this treatment is not treatment for 1 year but for 3 years. And the results published (inaudible) by the CoFAR were the 1-year result. So, it's very good to see that this is good confirmation.

 And I also have to say that we had, in the same time, the results of the part of the -- of our Phase II study of the placebo group. There was -- in the Phase II there were patient treated by placebo during 1 year, and then they were treated with an active treatment, and we -- once again, we had exactly the same results. So, we had three confirmation of the efficacy of the treatment.

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 David Schilansky,  DBV Technologies SA - COO   [21]
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 And also, on the CoFAR data -- this is just the top line results, obviously. There will be more coming. And they've looked very deep into different biomarkers. And some of them are definitely interesting to look at, and do confirm what we've observed in our preclinical data.

 So, there will be more to come to learn from this CoFAR trial, which was actually -- the only purpose when we launched this trial was to learn more about the mechanistic of EPIT. And it served its purpose in terms of validating what we've done previously, but also learning more about EPIT.

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 Susanna Mesa,  DBV Technologies SA - VP, Finance, US IR & Strategy   [22]
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 And just one last thing about CoFAR -- not to beat a dead horse, but again, in terms of safety, not one single SAE; not one single epinephrine due to treatment. And in terms of tolerability profile, we continue to see that the patients don't drop out. They don't want to leave the trials. They're staying in the trials. And in addition to that, 96% of them were also complying with treatment.

 And again, this is a 12-month evaluation. So, it's very encouraging to see that the motivation of the patients remains high, even if the treatment duration tends to be long.

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 Tazeen Ahmad,  BofA Merrill Lynch - Analyst   [23]
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 So, you're also now -- so, I'm sorry, go ahead.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman and CEO   [24]
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 Just to add something -- what the feedback from the centers, we had from the CoFAR study and from the new study, the Phase III study ongoing, is a lot of enthusiasm from the patients. And we have a lot of demands in the -- all the centers receive a lot of demands for patient to participate to the study -- much more than expected.

 And it shows, really, that the patients and the parents are really -- and the doctors, are really very happy to have this new treatment, just at 2 years to be launched on the market, hopefully.

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 Tazeen Ahmad,  BofA Merrill Lynch - Analyst   [25]
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 So, now you're on year 3 of collecting data from your VIPES study. And year 3 is actually an important year, because once your patients reach 3 full years of treatment, you're going to test the hypothesis of sustained unresponsiveness. And that is something that FDA has actually called out in its briefing or guidelines for approval of medicines for allergies.

 And so, can you talk to what exactly the structure is? How are patients going to be monitored for sustained unresponsiveness? They've been taking a 24-hour patch every day for 3 years. How does that change after year 3?

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman and CEO   [26]
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 David?

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 David Schilansky,  DBV Technologies SA - COO   [27]
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 Yes, Tazeen, you're right. There is this 3-year treatment. So, when you look at our trial, there is only one group of kids that have had 3 year of treatment when they reach year 3, with 250 micrograms.

 Today, we only have 20-ish patients in this group. They will be food-challenged at year 3 and then they will be asked to remain off treatment, which means basically no treatment for 2 months, without peanut consumption every day. And they will be rechallenged 2 months later. And we will see if they maintain their -- a certain level of tolerance.

 We don't mean that -- imagine they reach 2,000; they reach 2,000. But we want to have, still after this off-treatment phase, a meaningful improvement from day 1 -- compared to day 1. So, we'll have this data, probably H1 2017. It will be a trend, given the small number of patients that we have left in the study. It will be much more informative and clearer in the Phase III since we have 220 patients in the active arm from day 1.

 So, that will be an interesting information. But I'm not sure we can draw -- we will be able to draw conclusions in H1 2017 -- definitive conclusions.

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 Tazeen Ahmad,  BofA Merrill Lynch - Analyst   [28]
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 So, what would you define as -- in the minute or so we have left, as your next major catalyst for data?

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 David Schilansky,  DBV Technologies SA - COO   [29]
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 We have many, many, many catalysts. We have -- the pipeline is progressing in food allergy, in peanut, where we'll be closing recruitment, showing the 3-year data; in milk, where we'll be closing recruitment; and then in a year from now, showing the data.

 We'll be -- we also have a program in eosinophilic esophagitis in partnership with the Children Hospital of Philadelphia -- Jonathan Spergel is running this study. We'll be closing recruitment this year and showing the data in 1 year.

 So, it's true that in 1 year, H2 2017, we will have three major trials reading out -- peanut, milk and EoE. But in the meantime we also have work we're progressing outside of food allergy. We have a vaccine trial starting this year, and hopefully yielding results. It's a pilot trial in a whooping cough boost vaccination.

 And we have applications beyond food allergy, because we have is an immunotherapy platform. So, applications beyond food allergy, in Crohn's disease, potentially in celiac, or in hemophilia, that will give early-stage data, for sure; but data, still.

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 Tazeen Ahmad,  BofA Merrill Lynch - Analyst   [30]
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 Okay. I think we're just about out of time. So, thank you, DBV team, for presenting this afternoon, and thanks, everybody, for attending.

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 David Schilansky,  DBV Technologies SA - COO   [31]
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 And thank you, Tazeen and Bank of America, for this very busy day.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman and CEO   [32]
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 Thank you. Thank you very much.




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