Welcome to the DBV Second Quarter Financial Results and Business Update Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the three and six months ended June 30, 2024. This press release is available in the Press Releases section of the DBV Technologies website. Before we begin, please note that today’s call may include a number of forward-looking statements including, but not limited to comments regarding our clinical and regulatory development plans, the design of our anticipated clinical trials, the timing and results of interactions with regulatory agencies, our forecast of our cash runway and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company’s actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Please refer to the company’s filings with the SEC and the French AMF for information concerning risk factors that could cause the company’s actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, the company disclaims any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call. Joining me on the call today are Dr. Daniel Tassé, Chief Executive Officer of DBV; Dr. Pharis Mohideen, DBV’s Chief Medical Officer; and Virginie Boucinha, our Chief Financial Officer. I will now pass the call over to Daniel. Daniel? Daniel Tassé: Thank you Katie, and thank you everyone for joining our call this evening to review DBV's second quarter and first half 2024 financial results. For those of you who may be less familiar with our…

Thank you, Daniel. First, let's start with the tests. If you recall, this is a 600-patient study in 4 to 7 year olds with peanut allergy using the modified Viaskin Peanut patch. We have 86 sites across the U.S., Canada, Europe, UK, and Australia. The study is assessing the efficacy and safety of Viaskin Peanut over the course of 12 months of treatment. I'm really pleased with the progress that we have made. The test has been a company-wide priority, and it's taken a coordinated effort within DBV to get to this point. For example, our medical affairs team is small in numbers, but they are incredibly diligent and never fail to engage our multiple stakeholders at medical conferences. And of course, our investigators and their staff did a fantastic job. And we really appreciate the support that we have received from the patient advocacy groups and the academic societies. I must also thank our study participants, the parents, caregivers and subjects for their tremendous contributions. As we said in the press release, we anticipate to close recruitment by the end of the third quarter of this year. We estimate that top line results would follow approximately 12 months after the last patient is screened. We will certainly provide more detailed updates along the way. Let’s move now to the status of the COMFORT Toddlers supplemental safety study protocol. The FDA asked us to do a supplemental safety study in the one to three-year old patient population to add to the EPITOPE safety database in this age group. Following a Type C protocol meeting, we submitted the Toddlers safety protocol to the FDA in November of 2023. The agency responded with comments in March of this year. Since then, DBV and FDA have been engaged in ongoing dialogue. These exchanges…

Thank you very much, Pharis. So we'll now briefly review financial highlights for the first semester of 2024. And there are two highlights I would like to elaborate on, our cash run rate and our P&L, in particular operating expenses. So number one, we close H1 with €66.2 million of cash on hand and our cash runway now takes us into first quarter of 2025, which is an extension from prior communication where our cash runway was sufficient to fund operations until 2024 year-end. This extension is due to cost saving measures we have implemented and that we will continue to drive. There's another point I would like to highlight as we consider cash consumption in H1 of 2024. In the first semester, cash used in operations totaled $70 million, largely for ongoing clinical trials and for CMC and regulatory activities. It is important to note that H1 cash consumption includes $24 million of non-recurring costs such as comfort study, startup costs, move projects, supply chain activities. I will now elaborate briefly on our financials in terms of P&L. Our operating income amounts to $2.6 million for the semester and it is now exclusively composed of the research tax credit, the CIF French scheme following the termination of the collaboration agreement with Nestle Health Sciences. Operating expenses total $65 million that's plus 28% on last year, but it is driven by what really matters. That's Viaskin Peanut clinical and CMC activities, and again a third of it are non-recurring expenses. So for the semester we book a net loss of $60.5 million. So I'd like to reiterate that we continue to maximize the efficiency of our spend and remain highly disciplined in our cash management. That concludes the financial overview, and I'll turn the call back to Daniel for closing…

At this time, we will conduct the question-and-answer session. [Operator Instructions] And our first question will come from Jon Wolleben with Citizens JMP.

Hey, good afternoon. Thanks for the update and taking the questions. Maybe just one quick clarification on the label-in, label-out, and then I have some follow-ups on that. When you say patch wear time experience, do you mean how long the kids are wearing the patch or the experience they have while wearing the patch or an interplay between those two concepts? Daniel Tassé: Yes, important question Jonathan, thanks for asking. No it’s the former. It’s the fact that some kids wear the patch easily 24 hours a day. Other kids it varies more from one day to the other. So that patch wear time experience measured in hours of wear varies in some patients, and that’s the data that is rich to identify patients will be best responders in a nutshell. Pharis, is that a good way to put it?

Yes, that’s a good way, Daniel. The other way I like to think about it, Jonathan, is it’s kind of like a holistic experience, right? So not just is the patch there or not like an adhesion type of assessment, but it’s the day-to-day variability in the wear time. It’s the individual sensitivity, tolerability, itching, what kind of experience did they have? Was it difficult to wear it all day long or was it easy? There may be some lifestyle components in that that’s a little harder to tease out, but it’s not just one element. And as Daniel said, you can look at average daily wear time, but that doesn’t always tell you the story in terms of day-to-day variability. So I like to think of it as more of a holistic experience with the product. Does that help to kind of fill in some of the gaps there?

Yes. Well, does that make it harder to quantify them, though, than a simple number of hours worn?

No, not necessarily. We have – we just – it’s kind of the opposite. We have a lot of data, and we can look at a lot of different parameters. And with all of that data, you can get a pretty good sense of the type of experience the patient’s having. Obviously, we can’t talk to the patients, right. But there's so much data that we collect in our trials, that you can get a pretty good characteristic of these patients, and there's really quite a clear differentiation between those who are labeled and labeled out based on this whole accumulated data set that we have on them.

Got it. Okay. And then you guys said there's an association between a robust clinical efficacy response. I'm wondering if you could put some parameters around what you define as a robust response, and then what percentage of the EPITOPE patients were label and label out based on this criteria?

Does you want to take it or want me to take it. Daniel Tassé: Yes. I can, no, I can take it. Yes. So, at this point, because we're still in dialogue with the FDA, we are. It's probably not the best idea to throw out specific numbers and details, but we know this data set really, really well, and those numbers are robust in terms of what you've seen in the past from the EPITOPE results. And it is a pretty good separation between the two in terms of the size of those who are labeled in versus labeled out. I know that's kind of vague, but at this point, until we have final agreement with the FDA and have wrestled this down, it's probably nothing the right time to discuss it. But obviously, as we move forward, we'll present all of this in a public fashion.

Fair enough. Daniel Tassé: There's a reference point, I would add here, Jonathan, if I may. We have 67% overall response rate, so, obviously, the label lens would have a better response rate than that. By definition, it's a traditional enrichment strategy here, so. But the quantification will come down to the agreement we come to with the agency. If we can come to that agreement, the details will be shared at that point in time.

Got it. And one last one for me. Update on COMFORT Children, you guys don't have any expectations for feedback timing there it doesn't seem. Wondering, do you think that any progress with COMFORT Toddlers would help with COMFORT Children, or are there different issues and feedback from FDA there. Daniel Tassé: Yes, I'll take that one, Ferris. The two were intertwined. The ability to get to the right protocol design for COMFORT Toddlers was an element, obviously of COMFORT Children. So we wanted to solve for toddlers first, children will come next year as the next step in our discussions with the agency. But job one is to get to agreement in one year to three year olds.

Got it. Okay. Thanks again for taking the questions. Daniel Tassé: Please. Thank you.

[Operator Instructions] And it appears there are no further questions. Mr. Tassé, I'll turn the conference back to you. Daniel Tassé: I’m sure I'm not on mute, I'm not. Well, that concludes our call for this afternoon. Again, thank you. We are pleased with our progress the first half of the year. We look forward to achievement of the additional value creating milestones that I described this year and next. As always, we will keep you posted on our progress and I wish you all a very good evening.

This concludes today's conference call. Thank you for attending.