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: Samuel Slutsky - LifeSci Capital, LLC - Analyst
: Congrats on this awesome update. I guess on the approval process, what has to be done between now and BLA filing? Also, any recent
conversations with the FDA that are notable, just given some of the personnel changes they've had at the agency? And then as you think
about what an FDA label could look like, assuming approval, what's kind of your expectations there?
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DECEMBER 16, 2025 / 10:00PM, DBV.PA - Dbv Technologies SA Corporate Call
Question: Samuel Slutsky - LifeSci Capital, LLC - Analyst
: Got it. Okay. And just jumping over to actually the one to three-year-old safety study real quick. Just any update there as it relates to where
that's at on enrollment and kind of time lines, et cetera?
Question: Jonathan Wolleben - Citizens JMP Securities LLC - Analyst
: Congrats on the data. Long time coming. Got a couple on data and then a couple on the opportunity. Hoping you could provide a little
context on the clinical relevance of the primary endpoint. And then if you could provide any details on ending cumulative eliciting or reactive
dose that you saw for VIASKIN Peanut.
Question: Jonathan Wolleben - Citizens JMP Securities LLC - Analyst
: Cumulative reactive dose, yes.
Question: Jonathan Wolleben - Citizens JMP Securities LLC - Analyst
: Yes, as much as you can say. And then Daniel, you mentioned the 690,000 patients. Wondering if you could talk a little bit about further
segmentation into what proportion have multiple food allergies. Where do you think VIASKIN Peanut could fit in now that Xolair is also
available in children one year and older for multiple food allergies. Like how do you think about the addressable population for VIASKIN
Peanut?
Question: Sushila Hernandez - Kempen & Co - Analyst
: Congrats on the results. So on both (technical difficulty) how do you foresee both (technical difficulty) at some point? And then a question
on the patient compliance. Great to see this high level of patient compliance. Could you elaborate on the steps taken to increase the patient
experience with the patch?
Question: Sushila Hernandez - Kempen & Co - Analyst
: Yes. So with the patch in both -- for both children and toddlers, how do you see the patch being used? Will patients switch at some point?
Question: Sushila Hernandez - Kempen & Co - Analyst
: Yes, yes. That answers my question. And on patient compliance, could you just give the steps taken to increase the patient experience with
the patch?
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