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: John Walden - JMP Securities - Analyst
: And before I talk about the parallel path, can we start with the original PEPITES data? Because it's very strong dataset FDA disagreed with, I think
your interpretation, but that set us on where we are today. So can you review the data that came out of that trial and how we got to where we are
today?
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MAY 15, 2023 / 1:00PM, DBV.PA - Dbv Technologies SA at JMP Securities Life Sciences Conference
Question: John Walden - JMP Securities - Analyst
: I think an important comment to make is FDA in the CRL did not say anything about efficacy. It was all about adhesion --
Question: John Walden - JMP Securities - Analyst
: So can you talk a little bit about the design of the test and why you decided to do through challenges in that study as opposed to just measuring
adhesion?
Question: John Walden - JMP Securities - Analyst
: Yes. So study started a few months ago (multiple speakers) how's enrollment going and what are you thinking as far as timing of data?
Question: John Walden - JMP Securities - Analyst
: Okay. And then, a little over a year ago, I guess now, we got data from EPITOPE, your pivotal study in one to three year olds. Can you talk about
that data and then we can talk through the journey from there to today
Question: John Walden - JMP Securities - Analyst
: Exactly.
Question: John Walden - JMP Securities - Analyst
: And how do we think about -- based on what we know about allergy in general, what percentage of patients will outgrow that peanut allergy
naturally in the age group? And then are you seeing a greater delta between placebo and treatment? Or is that the accounting for the greater
response rates?
Question: John Walden - JMP Securities - Analyst
: So the difference between the response rates in EPITOPE versus VITESSE? It's due to that up rolling?
Question: John Walden - JMP Securities - Analyst
: So we have a really strong data in the toddlers with the original patch. We've talked about the ability to be flexible between manufacturing of the
two. Can you talk about what FDA said about moving forward in the one to three year olds on the backs of that data?
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consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
MAY 15, 2023 / 1:00PM, DBV.PA - Dbv Technologies SA at JMP Securities Life Sciences Conference
Question: John Walden - JMP Securities - Analyst
: And just last week, if I remember my days correctly, we had the publication in The New England Journal of Medicine of the EPITOPE data and
obviously it doesn't get any better from a medical relevance perspective. Can you talk a little bit about what that means for the program? And then
also, any new learnings from the peer review process and also the editorial I thought was also very interesting.
Question: John Walden - JMP Securities - Analyst
: Well, one thing that we really like to see is sometimes it's hard hearing the data, food challenge or eliciting dose or active dose. What does this
actually mean for parent seeing the data spelled out with what happens when a patient access eats peanut in the study? What happens when
you're on drug versus placebo? And then also the realization that you're in a clinical program to avoid peanut and be treated and you're still getting
exposure -- shows how necessary the treatments are.
Question: John Walden - JMP Securities - Analyst
: And the editorial, I think laid out the data very nicely, but also went through the pros and cons of epicutaneous immunotherapy, Viaskin Peanut
and oral immunotherapy, giving me flash backs to many years ago. But maybe you could talk through that dynamic and trade-offs in, especially
the toddlers?
Question: John Walden - JMP Securities - Analyst
: Yeah, I think the use case and the younger kids is even better than the 4 to 7 year-olds.
Question: John Walden - JMP Securities - Analyst
: And with the safety study in the toddlers kicking off, I think another important concept is not having a food challenge and that being a safety study.
You've done this dynamic before running an efficacy study at the same time as a safety study. Can you talk a little bit about enrollment timelines?
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MAY 15, 2023 / 1:00PM, DBV.PA - Dbv Technologies SA at JMP Securities Life Sciences Conference
And then also I'd have to imagine with the recognition again now with the New England Journal paper, people might be very enthusiastic to
participate.
Question: John Walden - JMP Securities - Analyst
: In your market research in parents and then physicians, what do you think the willingness to seek a new treatment is with the profile that you guys
have generated so far? Is it -- some parents care as a ton as if it's the scariest thing in the world? Does that translate into willingness to use or
willingness to prescribe from physicians would have you seen so far?
Question: John Walden - JMP Securities - Analyst
: Yeah. And that's consistent with the diligence we've done in clinicians and parents as well, that it's the convenience, the ease of use and the safety
-- all resonate very highly. And then the peace of mind is tremendously important.
And as we're bumping up on time, can you just remind us of the cash you guys have, how far that gets you? And then also news flow between now
to maybe the rest of the year? What should we be paying attention to?
Question: John Walden - JMP Securities - Analyst
: Well, it's great to see the progress and the groundswell from patients and parents and --
Question: John Walden - JMP Securities - Analyst
: Yeah. It's good momentum for you guys. And congrats on all the progress.
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