The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Jon Wolleben - JMP Securities LLC - Analyst
: And just a small piece of housekeeping, if you have any questions during our chat today, feel free to submit them via the chat function, and I can
ask on your behalf anonymously as we go through. Feel free to pepper Daniel as we go. But maybe for those who are not as familiar with the DBV
story or getting reacquainted with it, Daniel, I was hoping you could tell us a bit about the background of the Company, what you are focused on
as far as your mission and strategy in your core technology.
Question: Jon Wolleben - JMP Securities LLC - Analyst
: And for those who aren't as familiar with epicutaneous, when we talk about food allergies, historically there is oral desensitization, there is sublingual,
but you're really leading the way with epicutaneous immunotherapy. Can you tell us a little bit about how this actually works and how it's different
from the other approaches?
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JUNE 16, 2021 / 2:00PM, DBV.PA - DBV Technologies SA at JMP Securities Life Sciences Virtual Conference
Question: Jon Wolleben - JMP Securities LLC - Analyst
: And you mentioned your lead program, Viaskin Peanut. Can you talk a little bit about the unmet need? We see labels about peanut maybe part of
this product, and people trying to avoid peanut as much as they can. Does that work, does it not work? Why do we need a therapeutic intervention
here?
Question: Jon Wolleben - JMP Securities LLC - Analyst
: Got it.
Question: Jon Wolleben - JMP Securities LLC - Analyst
: Very much so. Let's dig into Viaskin Peanut a bit. It is your most advanced candidate. You have had some hiccups along the road, and I think maybe
going back through the history a little bit would be helpful for people to hear, given the progress you've been making recently. Last year, you
received the CRL from FDA. Can you tell us a little bit about what they said and what they asked you to do, and how you have been working to
address some of those issues from FDA?
Question: Jon Wolleben - JMP Securities LLC - Analyst
: No, that's very helpful. And I think -- can we talk about the CHAMP study as well, the one you've recently completed where you selected the two
modified patches? Can you tell us why the two patches, what did you change, how many did you look for, and what were the criteria to select
those?
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JUNE 16, 2021 / 2:00PM, DBV.PA - DBV Technologies SA at JMP Securities Life Sciences Virtual Conference
Question: Jon Wolleben - JMP Securities LLC - Analyst
: And can you remind me what is the expected use for the patch in the 4- to 11-year-olds? Is it wake up in the morning, slap it on, and then it stays
on until the next morning, and you replace it for a full 24 hours?
Question: Jon Wolleben - JMP Securities LLC - Analyst
: That makes sense. And can you remind us what adhesion looked like and how you're measuring it with the original patch? And then what is the
goal or the target for one of these modified patches that you are developing now?
Question: Jon Wolleben - JMP Securities LLC - Analyst
: Got it, okay. And I have one question because when looking back at your clinical data set, Viaskin Peanut was tremendously safe. The only thing
that popped up was occasional adhesion site reactions to the patch. And I'm wondering if these are going to stick longer, do you expect that to
get better or maybe get worse because it's sticking longer? Did you see anything so far in CHAMP as far as the adhesion site reactions that you saw
in the clinical trials earlier?
Question: Jon Wolleben - JMP Securities LLC - Analyst
: Got it. And you mentioned the EQUAL and the STAMP trials earlier. Can you tell us a little bit in more detail what you are measuring, the size of
these studies? What endpoints do you need to hit to answer these questions from FDA for both of these studies?
Question: Jon Wolleben - JMP Securities LLC - Analyst
: And I think you mentioned a really important point just now that you're not -- FDA did not ask you to do any food challenges in these studies,
which made us feel much more confident in their comfortability with the efficacy profile. So can you tell us a little bit about what you've seen in
the PEPITES study about efficacy? I know you technically missed a statistical threshold on the primary endpoint, but it was statistically significant.
So can you remind us of the profile and then how that interplays with this adhesion intersection with efficacy that FDA wants to see?
Question: Jon Wolleben - JMP Securities LLC - Analyst
: And coupled with the clean safety we already mentioned, it is a nice profile for a product, especially for younger children. And I guess -- so what
are the next steps as far as communications to the Street? When are we going to get some updates on these trials, your interactions with FDA, and
when we could be seeing this data in longer-term resubmission of the BLA?
Question: Jon Wolleben - JMP Securities LLC - Analyst
: So second half of the year is when we will get that update.
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JUNE 16, 2021 / 2:00PM, DBV.PA - DBV Technologies SA at JMP Securities Life Sciences Virtual Conference
Question: Jon Wolleben - JMP Securities LLC - Analyst
: Perfect. And you mentioned a couple other programs, milk and cashew. Can you give us a quick update on those programs? I know you've been
focused on Viaskin Peanut, but just touch base on where those are.
Question: Jon Wolleben - JMP Securities LLC - Analyst
: Absolutely. And then the obligatory last question, can you remind us of your cash position, and then what kind of runway that gets you? I know
you have just gone through a lengthy restructuring. Can you just tell us where you are on that front?
Question: Jon Wolleben - JMP Securities LLC - Analyst
: Excellent. Well, Daniel, I really appreciate the overview and the catching up on the progress this morning. I'm looking forward to hearing the updates
later this year and will keep an ear to the ground for all the good news coming from your end.
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