DBV Technologies SA Sponsored ADR Stock

Welcome to the DBV Technologies Third Quarter 2026 Results and Business Update Conference Call. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Kevin Gardner from LifeSci Advisors. Please go ahead, sir.

Thank you. This afternoon, DBV Technologies reported financial results for the third quarter of 2026. This update 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 forecast of estimated cash runway, clinical and regulatory development plans, the design and conduct of our clinical trials, our expectations with respect to the timing and results of interactions with and decisions by regulatory agencies 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 is Daniel Tasse, Chief Executive Officer of DBV.

I will now pass the call over to Daniel. Daniel?

Thank you, Kevin, and thank you all for joining us today. On the call today, I'm joined by our CFO, Virginie Boucinha; our CMO, Pharis Mohideen; and our Chief Operations Officer, Kevin Malobisky. Kevin is responsible for product engineering and development. He's responsible for manufacturing and for quality at DBV.

The third quarter of 2026 was a continuation of the work involved in becoming a commercial company. The highlight of the quarter was the filing of our BLA in 4 to 7-year olds, for which I will have to give a big shout out to the DBV team, to our investigators and to the food allergy community who have all been exceptionally supportive of our efforts. I also wish to recognize the FDA's constructive engagement in the last few months and look forward to working closely with them during the review process.

In tandem with this important regulatory work, DBV's manufacturing and quality management teams have been working closely with Fareva Amboise, the company's contract manufacturing partner. That work, which includes extensive collaboration with third-party expert consultants, follows the April 2026 FDA Warning Letter to Fareva.

As we previously disclosed, the letter resulted from a September 2025 inspection of the manufacturing of a veterinary product and it included some observations focused on quality management operations and systems, which makes the Warning Letter have site-wide implications at Amboise. It is understandable and reasonable that there may be questions about this and what this means for our review process and the potential approval of VIASKIN Peanut Patch in 4 to 7-year olds, and I hope to use some of our time today to discuss them.

So let me introduce Kevin to provide more details of the remediation process and our Pre-Approval Inspection preparation.

Thanks, Daniel. As Daniel mentioned, my name is Kevin Malobisky, and I am the Chief Operations Officer here at DBV. By way of a brief introduction, I've been in the pharmaceutical and biotech space for nearly 40 years, focusing my career on regulatory affairs and quality programs as well as building and leading teams through innovative development and operations. I joined DBV about 4 years ago. And as Daniel mentioned, I lead the global quality, development, manufacturing and Reg CMC teams here.

I would like to start by outlining and reviewing the responsibility and process for successfully addressing the Warning Letter received at Fareva Amboise. The responsibility for satisfactory remediation of the findings cited in the Warning Letter resides entirely with the company that received it, in this case, Fareva Amboise.

Since receiving the Warning Letter last April, Fareva has both accepted and embraced that responsibility and is working with DBV and our chosen third-party consultants on the remediation plan for the elements that could be applicable to manufacturing the Peanut Patch. Remediation of a Warning Letteris an established, standardized regulatory process, and I would like to take a few minutes to walk you through that and how Fareva has responded to the FDA and how FDA -- I'm sorry, and how DBV has been involved in the remediation process.

There are four parts. First, within 15 days of receiving a Warning Letter, our company provides a robust written response detailing the remediation plan. This plan includes proposed corrective and preventative actions or CAPAs, and the cadence on which they will provide the FDA with written updates. This is typically every 30 or 60 days until the remediation is completed. In this case, Fareva submitted their written response and their plan to the FDA within the 15 business days and has since provided monthly written updates to the Agency.

Second, as you may know, the remediation process is typically supported by external consultants and teams having remediation expertise. Many of these specialists bring deep knowledge of quality management systems and often include former FDA personnel. Where a question is highly technical or specific to a product, the remediation team can bring in additional subject matter experts. As I mentioned earlier, DBV's manufacturing and quality management teams are working closely with both Fareva and third-party consultants on remediation efforts that directly impact the manufacturing of the VIASKIN Peanut Patch.

Third, the work is managed against a detailed project plan developed by the company's management team and the remediation experts together with the company's quality teams. All progress is monitored against the plan and is the basis for the monthly updates provided to the FDA. In this case, Fareva shared its detailed project plan with DBV, allowing our teams of experts and our consultants to support elements of the remediation plan that may be applicable to the manufacturing of VIASKIN Peanut Patches. This collaboration has allowed Fareva to focus their resources on site-wide remediation, while also giving the DBV quality team direct access and line of sight into the work that matters most for the VIASKIN Peanut Patch production.

Finally, as remediation progresses and the company is confident in the date when the remediation will be complete, they will invite the FDA to reschedule a reinspection.

Now, what does all of this mean for our BLA? To be clear, the review of our application and the remediation of Fareva's Warning Letter are separate and distinct processes. Where they converge is with the Pre-Approval Inspection or the PAI, and its readiness. As is standard with FDA filings, DBV included a target date for PAI readiness within the BLA submitted to the FDA. That PAI readiness target date is after Fareva expects to have completed their remediation.

This background is important to understand how we are collaborating with Fareva and to reinforce how committed we are in the remediation process with them, specific to the elements relevant to the VIASKIN Peanut Patch.

I thank you for your attention and now hand it back to Daniel.

Thank you, Kevin. It should go without saying, the work Kevin and his team are doing is a priority for the company and will remain so until the remedial efforts -- the remediation efforts are complete. It's also very important that we not lose sight of the progress being made across DBV, and would now like to provide an update on our Toddler Program.

Over the last few months, we have also discussed with FDA our upcoming filing in toddlers aged 1 to 3 years as we're preparing to submit our BLA for children aged 4-through-7 years. These discussions included a potential rolling submission of the 1-through-3 BLA. Now we welcome hearing the FDA's perspective as we have a very unique dynamic here. We have two distinct BLAs to be filed in relatively quick succession. As we previously stated, no analogs exist for VIASKIN Peanut Patch. It's novel. We are building a breakthrough therapy on unique biology and a novel mode of action.

Now both BLAs share things and differ in many ways. Both BLAs share similar approaches to clinical development, although, it's an important although, although with two distinct populations and two large data sets. There are meaningful differences between the two clinical sectors. VIASKIN Peanut also, as you know, is a drug-device combination delivering a biological API. Thus, both CMC modules for both BLA -- for each BLA are large and complex, while still having important content overlap between the two.

But all of this background I'm sharing with you on commonalities and differences between the two BLAs matters because most importantly, both BLAs will be reviewed by the same team at FDA. And although there are obviously efficiencies to the overall review of the two BLAs, we do not want to create a review bottleneck and wedge two BLAs in parallel, potentially putting us at risk of doing just that.

Our goal is to solve for an expedient and efficient review of both BLAs as the outcome. We have discussions with the Agency and in those discussions, the Agency indicated that starting the 1-through-3 review shortly after the 4-through-7 review will allow them to build on the important learnings from the first review and also benefit from the efficiencies we expect given the meaningful content overlap between the two BLAs. But not only that, it will also give DBV and FDA an opportunity to align on the form, on the content and on the best timing of the components of a 1-through-3 submission, all in support an efficient review of both BLAs. And DBV is in full agreement with FDA's approach.

To give you a real example, we have asked for Priority Review in 4-through-7, and we certainly don't wish to take FDA's attention away from completing that review first and completing it efficiently. The efficiency of the subsequent review in our 1-through-3 application will clearly benefit from this well-coordinated sequential approach. We'll continue our dialogue with the FDA over the next few months and expect to submit a toddler BLA in 2027. We will provide an update once the FDA discussions of these elements have been finalized. And as a reminder, the FDA previously issued written communication confirming an accelerated approval pathway for the VIASKIN Peanut Patch in toddlers.

Now before opening for questions, I'll ask Virginie to take us through our third quarter financial results, cash position and highlights. Virginie?

Thank you, Daniel, and good afternoon, everyone. We ended the third quarter with USD 165.7 million in cash and cash equivalents. This includes $50 million in gross proceeds from the sales of ADSs to RA Capital under our refreshed ATM program. Following the BLA submission, we updated our operating and liquidity forecast. And on this basis, we estimate that our existing cash will fund operations into the third quarter of 2027.

This forecast reflects a stage-gated approach to investment. Our spending assumptions are milestones-based, so the timing of certain expenditures is aligned to regulatory developments, while we keep funding what the FDA review and a potential launch require. This means continued investments in Medical Affairs, Market Access, Marketing, Account Management and Pharmacovigilance as well as in our launch infrastructure.

Now turning to our P&L. Year-to-date operating expenses were USD 164 million -- USD 166.4 million compared with $107 million a year ago. That is an increase of $59.4 million. About half of this increase went to the clinical and regulatory work behind the BLA filing itself. And this investment also reflects the ongoing advancements of COMFORT Toddlers, its open-label extension, VITESSE open-label extension and THRIVE. The other half of our investments went to building a commercial-ready company.

Sales and marketing grew from USD 1.9 million to $15.7 million as we build our commercial expertise and launch infrastructure. We also continue to build pre-commercial inventory and scale the corporate functions that will support commercialization. The third quarter was a quarter of execution. We submitted the BLA and laid the foundation to become a commercial organization, and we will keep pacing our investment to regulatory milestones.

With that, I'll turn it back to Daniel.

Virginie, thank you. In closing, the third quarter represented an important step forward for DBV. With our BLA for children aged 4-through-7 now submitted, we are focused on supporting an efficient FDA review, working with Fareva and advancing manufacturing readiness and preparing for the potential commercialization of the VIASKIN Peanut Patch, if approved. At the same time, we remain committed to expanding the potential reach of our technology to younger children through our Toddler Program.

We recognize the important work ahead. We'll enter the next phase with clear priorities, energy and disciplined execution. We look forward to keeping you informed of our progress.

So we can open the line for questions now, operator.

[Operator Instructions] And our first question comes from Kristen Kluska of Cantor Fitzgerald.

Really appreciate all the color you provided today on the manufacturing progress. I had a few questions there. Just understanding the process, is Fareva sharing with you the monthly updates that they have in terms of what they're submitting to the FDA and what the feedback has been? And then, are you able to say whether or not the actual FDA reinspection has been scheduled? And just trying to understand when we, the public, might be able to understand when that is and what the outcome eventually is?

So Kristen, I'm going to take that one. They share with us a lot of the monthly report, but understand they have 70 customers, they make 100 products. A lot of these things are not for competitors or other companies to see here. So we're quite satisfied with the extent of what they share with us. It's more than adequate for us to be comfortable with the progress, but we don't get to see everything for those reasons. Makes sense?

To your second question, the FDA visit has not been scheduled yet, but it would be a bit premature to do that. Again, as these things progress, that would be part of what we'll be happy to share with investors as we cross those steps. Does that answer your question, Kristen?

Yes.

Our next question comes from Sushila Hernandez of VLK.

Just to clarify, so is Fareva currently tracking its detailed plan? And is there sufficient time for complete remediation with a potential buffer for potential delays before the preapproval inspection? And second one, have you completed and analyzed the data of the COMFORT safety study in toddlers? And last question, so is this then -- will you submit the toddler BLA only after a complete review of the children BLA? Could you elaborate on that?

Thank you. The last two questions on toddlers, I'll have Pharis answer them, while we'll answer your question about the remediation process afterwards. So Pharis, do you want to walk us through where we are with toddlers and the dialogue to come on what is the form of submitting that data since that discussion is not taking -- yet fully taking place with the Agency. So Pharis?

Yes. So if you recall, COMFORT Toddler recruitment ended in the second quarter. It's a supplemental 6-month safety study. So you can add up the timing for that. I think the important point, as Daniel mentioned, is going to be related to the ongoing dialogue with the FDA related to the timing of the 1-to-3 BLA relative to the 4-to-7. And to emphasize what Daniel said, we've been in close correspondence and dialogue with the FDA. The last thing we want is the 1-to-3 to create a bottleneck or a delay in their ability to deliver the Priority Review for the 4-to-7 BLA.

Of course, nothing stops us from submitting the BLA if we want to, from a regulatory legal standpoint, but that's not the spirit of the relationship we have with the FDA. So I'm not sure if that exactly answered your question, Sushila, but I think behind what you're asking and getting to is what Daniel had addressed.

Yes, that's clear.

Okay. And Sushila, if you could repeat your first question? So if we give you a precise answer, would appreciate that.

Yes. So is Fareva tracking its detailed plan that they have laid out? Is it on track with all the steps? And is there sufficient time for complete remediation before the Pre-Approval Inspection?

I'll have [indiscernible] Kevin answer that one. So Kevin?

Thanks, Daniel. Yes. So as I mentioned, we work very, very closely with Fareva, as well as a number of consultants on a daily basis, and we're quite comfortable with the progress that they're making in terms of the remediation. The timing of that reinspection as it relates to the timing of our PAI we're also very comfortable with in terms of the buffer that would be there.

Our next question comes from Jon Wolleben of Citizens.

I might have missed this, but can you discuss what the Warning Letter details included, and what remediation activities are still ongoing? And then, any thoughts on getting a second manufacturer to have redundant supply? Or is that something that is a little too late in the game at this point?

Let me start with the second half, and I'll have Kevin answer the question here on the remediation process. We need a second manufacturing unit somewhere in the world to support the other years of our forecast that we shared with investors here. So we need more capacity, but that's investment we're making to support the full site of the product at approval. Setting up a new facility takes about 3 years, whether it's a CDMO or your own site here. So that obviously is not the backup plan to Fareva. Our plan with Fareva, and again, we're confident, is to work through the remediation and launch essentially the product out of their capacity. Does that make sense?

To your first question, Kevin, can you answer it? Or do you need Jon to restate the question?

No, I can answer it. So the focus of the FDA inspection that led to the Warning Letter, as Daniel had mentioned earlier, was on a veterinarian product and an aseptic manufacturing process at their site. It's completely separate from the work in -- that's ongoing on the VIASKIN Peanut Patch. That being said, the remediation against a site-wide look at how potential impacts to the aseptic filling and the citations against that may or may not relate, is what's ongoing in the remediation. And again, we're very comfortable with the progress that Fareva is making and the expertise that we have on hand to continue to track that closely.

And by the way, that Warning Letter is available publicly, Jon, and we can save you some clicks of the mouse and send it to you. But it outlines essentially exactly that and observations around general quality management systems and training and that -- but those comments are common in a Warning Letter. And when such comment is made, obviously it touches every product made there as opposed to simply limiting it to the original observation, which was this veterinary product. I hope that was helpful as an answer.

[Operator Instructions] And our next question comes from Yatin Suneja of Guggenheim Partners.

I appreciate all the color you provided. So I mean -- so I don't have a question on the CRO or the CMC. It's more around what do you now expect? Do you still expect a Priority Review? I mean, given that it's a faster process, if you get a Priority Review, do you think you have enough time to address all of that? And then the second part of the question is if you get -- do you -- would you also -- are you also eligible for a Priority Reviewvoucher? And how you think about sort of monetizing it if you get one of those?

Thanks for those two questions here. So I'm getting on here. The first half of your question was what, Yatin? The second one is on the priority voucher and then market...

Yes. The first one is more around, do you still expect a Priority Reviewfor this application?

Yes. Thank you so much. Yes, we do. We are eligible for Priority Review given our breakthrough designation. At the Agency, the decision of giving Priority Review to a breakthrough product does not belong to the Review division, but to a different team at the FDA. So the decision is made independently from the Review division. So the request has been made. A large percentage of companies with breakthrough designation do get the Priority Review. So that remains our hope here, and I would say expectation, but it's really our hope here.

All of our planning, whether it's launch planning or whether it is remediation and preparation for the PAI, is all hinged on what would be a Priority Review. So we're not giving ourselves any extra buffer time here. We're planning for the best case scenario, which is a tight timeline. We remain comfortable that all that can be managed within the clock of Priority Review.

To your second question, the rules by which we could monetize access to a pediatric voucher would assume that the population, obviously, is less than what is the target population, so 250,000 to 300,000 kids, arguably 1-to-3 is a bit less than that. But the rules for Priority Review assume that the technology cannot be used in other populations, which obviously is the last thing we want to stick with VIASKIN Peanut here. We believe we can help kids 1-to-7 and also kids as they grow out of 7, they're still eligible to be on therapy. So unfortunately, the strictest definition of the rules for priority voucher would not apply to VIASKIN Peanut and not for lack of trying. [indiscernible] can answer your question. And then...

And then maybe one more question. Yes. No, that's very helpful. And then one more question, if I could, on the commercial side. Perhaps maybe talk about some of the prep you are doing on the commercial front. What type of a team you are able to hire now? I understand most of the sales force come after or closer to the launch. But maybe talk about that, when could you be launch ready?

Yes. We don't have Kevin Trapp on the call. So obviously, he's the best person to answer those questions, but I've discussed, been working with him very closely. So to give you the highlights, as you know, there are 4,500 allergists in the U.S. They treat the bulk of the patients with food allergies, including peanut. We're looking at sales force of 50 to 70 people to target them. Parents are important to the commercial mix here.

So our ability to build the right mechanism, the right outreach to media, to engage a dialogue with them is a big part of our marketing plan, and also, as is obviously engaging with payers to make sure that not only do we get a price that we think is fair for the therapy, but a review process or prioritization process by allergists that will be relatively straightforward. So all these key elements of our marketing plan here. And as you saw from our P&L for the first 9 months of the year, we are making those investments wisely.

Obviously, building up inventory to launch the product comes a bit later on. Obviously, hiring a sales force comes towards the end of the process. But many of the key investments we are making right now because you don't launch a blockbuster on 6 weeks of preparation, you launch a blockbuster on 18 months of preparation. We're just being, I think, very smart, very strategic and very, very planful in making those investments as we move forward to the derisking of the product vis-a-vis theAgency. Hopefully, that was helpful.

Our next question comes from Sam Slutsky of LifeSci Capital.

Two for me. Does the breakthrough therapy designation and potential for Priority Reviewalso apply to 1-to-3? Or is that strictly a 4-to-7 age group thing? And then the other question was on COMFORT Toddlers, is that basically just a box check press release of [ higher ] safety in line hopefully with prior studies? Or what might we see in that press release?

Yes. So I'll come to the toddlers headline results here. To your first question, it's untested whether or not one breakthrough designation could support two BLAs. So we are on uncharted territory here. But we do have the opportunity given our accelerated approval pathway in 1-to-3 that also comes with eligibility for Priority Reviewin that process. So our thinking right now is Priority Reviewas a function of breakthrough designation supports the request made in 4-to-7, and then the other one would come with the accelerated approval pathway offered in 1-to-3. To be very clear, I'm sharing with you what our thinking is here. We don't have those answers. We don't have those commitments from the Agency yet. Does that make sense?

Yes. And then just on the second question...

Did that include the whole question or...?

That was the first question. The second question was just on COMFORT Toddlers. Is that going to be just kind of a box check press release that will be saying safety is hopefully in line or what will be in that press release, you think?

Yes. We will obviously press release the results here because -- and I'll have Pharis add to this here. The pivotal study is EPITOPE. It's been completed. This is a supplemental safety study. There are many ways to provide that to the FDA as part of the BLA, including as a safety update later on in the process here. All those discussions will take place with the Agency going forward. But yes, I think it would be wise for us to announce the results once we have them to say the study completed. And also, we expect that we'll show no safety data that would be a deviation we've seen historically, but I'll invite Pharis to add his 2 cents worth here since this study -- and it's his publication team.

Thanks, Daniel. I would agree with that conclusion that. Sam, we have like a 2,000-patient database over the years, and this product is very well characterized. So if anything did come of that, it would be very out of characteristic for the product, which we don't expect. So to answer your question directly, it would pretty much be a check-the-box type of press release. As you know, for the safety studies, at least for the nature of the safety studies we do, there's no primary endpoint, and it's not powered to show a specific thing. So it's all about meeting exposure numbers for the product. So very much, in my mind, at this point, a check-the-box type of press release.

Our next question comes from Gavin Clark-Gartner of Evercore ISI.

I appreciate all the manufacturing updates. So I'll just stick on that theme here. Could you just walk us through like the scope of updates and the time lines for what you're expecting to update us on over the next 6 or 7 months as the review progresses? Like you have the remediation activities. I see in the 10-Q, there's a mock PAI, small milestone with the February 1 date listed. I obviously have like when the PAI gets scheduled. So I'm just wondering like what we should be expecting to hear from you guys over the next 6 or 7 months?

Correct. I want to make sure that I'm clear here, and there's no misinterpretation. February 1 is the date we have shared with the FDA that we'd be ready for an inspection. And there will be mock PAI before that. It's not uncommon for manufacturers to do regular mock inspections, some surprise, some planned. It's the way we make sure that our CDMO stay sharp. We do the same thing with our own plant, by the way. So there's going to be a number of inspections along the way to make sure we verify readiness. And obviously, those developments could be relevant and could be something that we choose to share with the market as the dossier progresses here. Does that answer your question?

That's helpful. Yeah, it is.

[Operator Instructions] And our next question comes from Theodora Beadle of Goldman Sachs.

So firstly, to what extent have you already had discussions with payers ahead of the potential VIASKINPeanut approval? And what has been the early feedback from that process? And then secondly, how should we think about the first year sales potential for VIASKIN Peanut in age 4-to-7-year olds?

Yes. I'll start answering your second question. We will not be providing guidance. We will have obviously a launch day for the benefit of investors and analysts as we get closer to launch and Kevin Trapp will do a masterful job of walking you guys through how we think about the market so they can help us track it with us here.

As far as conversations with payers, I see it obviously to be relatively limited at this point in time. It is part of launching a product. It is amongst those investments we should make prior to launching a product, is to understand everything about payer and payer dynamics, everything from health economic outcome research arguments for the price as well as analysis as well as understanding what would be the prior authorization process, which is likely given the nature of the product and of the indication.

Those discussions have been going on. We have account managers talking to all the big payers in the U.S. already. And all of this has been folded into what is, as you know, a commercial strategy where outreach and coordination with payers is a big part of the value creation. But I'm very pleased with the efforts that Kevin and his team have led on that front. I trust that answers your question.

And this concludes our question-and-answer session. I would like to turn the conference back over to Daniel Tasse, CEO, for closing remarks.

Carl, thank you. Nice job. Everybody, thanks for joining today. Thanks for the questions from the analysts. That concludes our call for this afternoon. I appreciate your time. I appreciate your engagement, and have a wonderful evening. We'll talk to you soon.

Welcome to the DBV Second Quarter 2026 Results and Business Update Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Jonathan Neely, Investor Relations. Please go ahead, sir.

Thank you. Good afternoon. DBV Technologies reported financial results for the second quarter and half year of 2026. This update 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 forecast of estimated cash runway, clinical and regulatory development plans, the design and conduct of our clinical trials, the timing and the results of interactions with regulatory agencies 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 Daniel Tassé, our Chief Executive Officer; as well as Pharis Mohideen, our Chief Medical Officer; and Kevin Trapp, our Chief Commercial Officer. I will now pass the call over to Daniel. Daniel?

Thank you, Jonathan, and thank you all for joining us today. 2026 is and will continue to be a pivotal year for DBV. We are working aggressively to transform the company into a commercial organization in anticipation of the potential approval of the Viaskin Peanut patch for children aged 4 through 7 by the FDA. It's certainly a tremendous amount of work to move from the clinical to commercial stage. So today, we'd like to walk you through a summary what we've accomplished toward that goal in the first half of the year.

Pharis and Kevin have joined me today to help describe how we have advanced our lead program toward BLA submission, continued constructive engagement with FDA, expanded the Viaskin Peanut clinical program and strengthened the foundation required to become a commercial stage company.

I'll start with the status of the BLA. As we shared 2 weeks ago, we continued to optimize our BLA submission for the Viaskin Peanut patch in children age 4 through 7 through our engagement with the FDA, which has been constructive and collaborative. These discussions have been particularly valuable for a novel first-of-its-kind product like the Viaskin Peanut patch, and let me reiterate the FDA has not requested additional data. The work underway is focused on incorporating FDA's feedback related to the organization, the mapping and formatting of existing CMC and biostatistical data sets. We believe this is the right work to do now since our objective is a timely and efficient review of the BLA for VP in 4 to 7, and we plan to submit and optimize BLA in the third quarter of 2026 to support an efficient FDA review.

In addition to these conversations, our progress in the first half 2026 include important developments in our clinical program, and let me invite Pharis Mohideen, our Chief Medical Officer, to tell you a little bit more about that.

Thank you, Daniel. While much of our team is laser-focused on BLA preparation and submission, we are also working hard to continue to build our scientific platform. So today, I will share an update on 4 main topics: the COMFORT Toddlers, the tests, THRIVE and whether or not the prevalence of peanut allergy has changed over the last 10 years.

First, let me start with COMFORT Toddlers. I'm pleased to say that in the second quarter, we closed the recruitment for COMFORT Toddlers, a supplemental safety study evaluating the Viaskin Peanut patch in toddlers age 1 to 3 years. This is an important milestone as we look to progress this program.

About VITESSE, we presented new data from our Phase III study in 4- to 7-year olds at the American Academy of Allergy, Asthma and Immunology Annual Meeting earlier this year. This data included additional efficacy assessments, demonstrating consistency of the treatment effects regardless of baseline eliciting dose and across multiple statistical subgroups. And last month, at the European Academy of Allergy and Clinical Immunology Congress, we presented the test data showing that subjects with asthma, eczema and/or other food allergies, common comorbid conditions for our study population had no difference in the Viaskin treatment effect. This is an important dimension of the treatments of food allergies and peanut allergies since they are often accompanied by other atopic conditions.

The population of children we recruited in VITESSE is very typical of the overall peanut allergy population seen in allergists' offices. This data reinforces our confidence in the potential role that the Viaskin Peanut patch may play both for allergists who are navigating the everyday complexities of the food allergy population and for families who are looking for a practical treatment that fits into their everyday lives.

Also at EAACI, the design elements for THRIVE were presented by Dr. Kirsten Perrett, who is the co-lead investigator, along with Professor Gideon Lack. THRIVE is assessing the efficacy and safety of the Viaskin Peanut patch in achieving ad lib consumption of dietary peanut in infants with peanut allergy aged 6 through 12 months following 3 to 4 years of treatment with the Viaskin Peanut patch.

We are pleased to have shared the first subject was enrolled in this first-of-its-kind study last month at Dr. Doug Mack's site in Canada. We believe this study is nicely aligned with earlier introduction of allergens into the diet and consequently, more patients being identified with a food allergy at an earlier age.

Given the positive results of the Phase III EPITOPE study in 1- to 3-year olds, which was published in the New England Journal of Medicine in 2023, we believe that the THRIVE study has the potential to be a landmark study.

We pay very close attention to the ever-evolving food allergy treatment landscape. And a question that we frequently get is whether the prevalence of peanut allergy has changed. I'd like to take a minute to discuss an important recent publication that informs discussions of the prevalence of IgE-mediated food allergy across children and adults. Dr. Alessandro Foti, a leading allergist, and colleagues, conducted a standardized survey-based study of peanut allergy prevalence in children using a methodological approach deemed by the FDA as sufficient to produce evidence of high to medium strength. In the United States, the study reported a 2% prevalence of peanut allergy in children. That estimate is broadly consistent with prior U.S. literature, including the approximate 2.2% prevalence rate previously reported by Dr. Ruchi Gupta and colleagues in 2018.

Importantly, the Gupta data were collected in 2015 and 2016, while the Foti data were collected in 2022 and 2023. These 2 independent data sets collected approximately 7 years apart both point to a U.S. pediatric peanut allergy prevalence of approximately 2%. The confidence intervals further support that conclusion. Gupta reported a 95% confidence interval of 2% to 2.5%, which overlap with the estimates across each pediatric age group in the Foti paper.

I'll hand over to Kevin Trapp to put this new prevalence data into a commercial context. Kevin?

Thank you, Pharis. For us, these findings are highly relevant because they reinforce that the opportunity in peanut allergy in the U.S. has not changed. This is an important point. The Foti data reinforces that peanut allergy remains a persistent population-level issue. Despite early introduction, the peanut allergy patient population remains largely consistent. Peanut allergy also remains one of the most common food allergies in children and it still creates a daily burden for patients, families and health care systems. That is why our work matters and why as we move toward BLA submission, we're planning now for what it takes to bring Viaskin Peanut patch to the market at scale, if approved.

For commercial, that means focusing on building the infrastructure a successful U.S. launch requires. We are investing across market access, patient services, brand readiness, field force planning and launch operations. We have built the launch model around cross-functional execution. Commercial is working closely with medical affairs, our regulatory team, pharmacovigilance, quality, supply and manufacturing so that the launch planning is connected to the evidence, our safety systems, product supply and the regulatory time line. Our goal in the end, to ensure a prescriber and patient experience that supports their needs and fits into their daily routines.

It looks simple on the front end, but is so complex on the back end. We're also spending real time with the food allergy community, including caregivers, advocates, physicians and payers to understand where the greatest barriers exist and DBV can support adoption of the peanut patch.

In short, we're doing the work now to drive both a successful launch and the long-term growth of Viaskin Peanut patch. As part of that longer-term planning, we're taking a close look at company operations that would be required to support potential peak demand for the Viaskin Peanut patch, if approved. So we're reviewing what the future would look like for our manufacturing capacity, supply chain readiness and related capital requirements.

We believe the opportunity is significant and that the patch has the potential to transform treatment in a large market with significant unmet need. Our planning must reflect that potential.

Daniel, I'll pass it back to you.

Thank you, Kevin. I would like to emphasize Kevin's last point. The planning that we're doing and the foundation we're building reflect our belief in the potential of Viaskin Peanut patch. At the same time, we always approach these investment decisions thoughtfully in alignment with regulatory progress, commercial readiness and disciplined capital allocation.

So in closing, the first half 2026 reinforced our conviction in DBV's future. We are advancing our lead program in 4- to 7-year olds towards BLA submission. We have closed recruitment for COMFORT Toddlers supplemental safety study in 1- to 3-year olds. We are expanding our Viaskin Peanut clinical program with a very important THRIVE study. We are funded into the third quarter of 2027 to support operations and commercial preparedness, including investments across our core functions required to potentially launch and support the Viaskin Peanut patch.

Now we're doing all of this with a clear purpose, to help children and families living with the daily burden of peanut allergy.

I will now pass it over to the operator for questions.

[Operator Instructions] And our first question comes from Yatin Suneja at Guggenheim.

So just 2 quick questions for me. First is with regard to the filing and the acceptance and the time lines around it. So what are your working assumption? Like how should we think about the acceptance time lines? Will this be a standard review or a priority review?

And then with regard to the CMC readiness and commercial supply, are there any implications from the FDA feedback, any changes in manufacturing dossier or anything you sort of have to do from a launch perspective?

No, thanks for those questions, Yatin. Let me start with the first one. So the regulatory time lines are, we will be asking for prior review given the fact that Viaskin Peanut, the platform has a breakthrough designation, thus making us eligible for priority review. As you know, that request is made formally when you file the BLA. We're working closely with the agency on the content of that BLA. That was the purpose of the update a few weeks ago here. So after we file, it's up to 60 days for the agency to accept the file for review and share whether or not the sponsor is given priority review. Right now, we're assuming 60 days. Could it be shorter, there's a possibility given how closely we're working with the agency, but the formal time lines are 60 days. We'll ask for priority review, which would be a 6-month review at that point in time. I hope that answers the first half of your question.

On CMC, no, the discussions with the agency on CMC are essentially now completed. We've had all their comments. We're in the process of making the adjustments that they want here. So there is nothing that the agency has asked us to do that represents a change in any way, shape or form to the way we manufacture the product and the way we will describe that in the Module 3, the CMC section of the BLA.

Got it. One more question, if I may. Now -- like what is now the gating factor? Or what are some of the things that you need to get either an alignment or, or you have to complete it on your end? Can you just tell us before you can submit the BLA?

Yes. There are discussions ongoing, Yatin, as you know, on CMC and also on formatting, tabulation of the biostats table. So that discussion is also going on in parallel. So completing the discussions with the FDA and CMC and the same completion on biostats are the 2 gating items right now progressing in parallel.

And our next question comes from Sushila Hernandez of VLK.

I also have 2. So do I understand correctly that you have engaged with the FDA since the last conference call that you organized? And if so, have they provided with additional suggestions on the structuring, mapping of the BLA package or in any other fronts?

Yes. Okay. So those are 2 questions, Sushila? So the short answer is yes. The dialogue with the agency is ongoing, dialogue is both talking as well as exchanging e-mails. And yes, there's been further discussion of what they want, all of which are things that we're accommodating within. Again, nothing that is being discussed right now requires incremental data or we see as being fundamentally problematic in any way.

I trust that answered the 2 halves of your question?

Yes. And then just 1 more. So with the recruitment concluded of the safety study in toddlers, could you just remind us for how long you will follow these toddlers before the study is completed?

Pharis, you want to take that one? It's your baby?

So with -- yes, with the recruitment completed -- sorry, go ahead.

No, it's a 6-month safety study. Again, there's no efficacy component to it. We did the food challenge upfront to have inclusion/exclusion, but it's a 6-month treatment period.

And our next question comes from Kristen Kluska of Cantor Fitzgerald.

A couple of questions from me. First, I think most of us on the line probably have never submitted an application before. So can you help us just try to imagine what it's like to reformat things? Why isn't it as simple as just copy and pasting in other areas? Sorry for the basic question, but I think it will help since we don't have this experience.

I appreciate that question, Kristen, because it really is critical. Yes. There's nothing you do in an office that looks like filing a BLA. This is not a ZIP file you attach to an e-mail. This is not a link to some data site when it comes to doing due diligence. It's a massive, massive document that includes literally hundreds of thousands of pages and tests and validations and protocols, all organized in a way that's obviously delineated under the regulations of the CSRs. And then all of this includes a lot of hyperlinking so that the FDA can easily or as easily as possible navigate from one element to the other one. In all of that, that rigor and structure needs to be done in a way that is formatted to FDA standards; one, for their ease of review; and two, to make sure that given the size of that file, there's no issues through the FDA sort of IT firewalls.

And to add to that to the sense of the massiveness of the undertaking, since there's a lot of linkage of something that's in one part of the BLA to another one, a big part of what sponsors do to verify that all of those linkages work and that as you change something, you don't change something in a domino document later on. It sounds like a lot of small things, and that's exactly what it is. It's a lot of small things.

I don't know if that answers your question here, but it's a massive undertaking. It's all about details.

And then on COMFORT Toddlers, just are you still planning to file that later this year? Or how should we be thinking about that based on the time to collect the safety data?

Yes, we are still planning to file by the end of the year. COMFORT is a supplemental safety study. The pivotal trial is EPITOPE. Let's not forget that, that's already completed here that shows efficacy. We talked about the amount of commonality and overlap in content of the BLA 1 to 3, 4 to 7. That's obviously part of things we're learning as we work closely with FDA in 4 to 7. So we maintain our objective of filing by the end of the year as we work through that logistic. And obviously, that will be in dialogue with the FDA, obviously.

And our next question comes from Jon Wolleben of Citizens Capital.

A couple on commercial for me. Do you guys have any sense of the average price of Xolair in 1- to 7-year olds, and what pricing band you guys have been testing with payers?

Kevin, can you take that one?

Sure. Yes. As you know, I mean, Xolair is IgE and weight based, so it will vary across that age range. We've seen prices from around $10,000 into the 30s, right, depending on that. We've tested a range of prices. I mean we're not going to finalize anything yet. We've got payer discussions that will be upcoming here in the next month, advisory boards. But the research is being done. And as we get tighter on this, we get close to launch, we can give you some more ranges.

Okay. And then when we think about commercial, do you have a sense in your research what proportion of 1- to 7-year olds with peanut allergy would seek some form of therapy? And then digging into that, who would be a likely candidate for Viaskin Peanut versus who would not be?

Kevin, Can you take that?

Yes, sure. Yes. I mean, look, we've done a lot of both parent research and allergists research. And I would say that we always see very significant demand as we talk to parents. And we know it's not one market. So as we continue to look through segmentation and who will activate first, we think there's a number of things in our framework from those that have just been diagnosed or just had a reaction. Those that have already sought out immunotherapy, but perhaps didn't continue with it for either the burden of frequency of visits or the tolerability. And then there's a group that maybe get farther out in their avoidance at Epi, and they may need more education and they'll be like later down the path. So we have got our framework done. We're doing a lot of work on kind of segmentation and prioritization. And again, I think we'll have more to say to that in the second half of the year if we're talking about a commercial day at some point. So is that helpful?

Okay. It will be more helpful around the commercial day, but I appreciate you guys taking the question.

[Operator Instructions] And our next question comes from Sam Slutsky of LifeSci Capital.

Just in terms of the THRIVE study, could you remind us what the ultimate goal of that is in terms of, are you expecting to eventually get a label change with it, whether it's age groups or just the language around treatment in general? And just kind of what's the end goal of that study, hopefully?

Pharis, you can start I can yelp you with.

Yes. So this is a Phase II study. It's really almost more of a proof-of-concept study, Sam. So the objective, and this is sort of trampling in off of the 1- to 3-year-old success that we saw in EPITOPE at that age group. So we're going a little bit younger. As you know, younger patients tend to have a more responsive immune system. And the ultimate goal is to see these if patients can get to the point where they can consume peanut ad lib. And we have a very broad definition because one size doesn't fit all in this patient population.

At this point, we're running the study. It's not really intended to be a registration study. It's a single-arm study. We've not talked to agencies about what this data set could do. We just started recruitment, as I mentioned. It's in its early stages. But for us conceptually, it's a natural study to do given the data that we presented with desensitization and sustained unresponsiveness. And with the introduction of food allergens earlier, this population absolutely does exist, right? So it's early stages, Sam. Again, right now, we're going to run the study and see where we end up. If we choose to dialogue with the agencies in the future, we'll have those conversations. But for now, it's open sites recruit and see what the study shows.

I'll add 1 thing, Pharis, if I may. What's not changing here is what is the duration of treatment, right? We expect kids will be on therapy for 3, 4, 5 years. We're trying to do the same thing here in 6- to 12-month olds. So we could have decided to do this study as part of a Phase IV study post approval. I think the question is too important and too pressing to wait that long, moreover, I mean we're running the study with obviously some degree of confidence given what we know about our product that it is going to show some benefits here. That's why we're calling a Phase II study. But it's a question that deserves to be answered, and it does not change the treatment paradigm of using Viaskin Peanut in toddlers who're peanut allergic. Is that helpful, Sam?

Yes.

And this concludes our question-and-answer session. I would like to turn the conference back over to Daniel Tassé for any closing remarks.

Okay. Well, thank you. That concludes our call for this afternoon. Again, we are very pleased with our progress towards commercialization, remain committed as we're answering your question, is it transforming the lives of children families living with daily burden of food allergy. It is a burden. We think we have a technology that can make a big difference there. And we're proud of the work that we're doing and the science that we're pursuing to try to change the life of families. So thank you. Good evening, and we'll talk to you soon.

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

Good day, everyone, and welcome to the DBV Business Update Conference Call. [Operator Instructions] Please note, this call is being recorded. Now I would like to turn the conference over to Jonathan Neely, Investor Relations. Please go ahead.

Thank you. This afternoon, DBV Technologies provided a regulatory update for the Viaskin Peanut patch for children aged 4 to 7 years. This update 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 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 is Daniel Tassé, Chief Executive Officer of DBV. I will now pass the call over to Daniel. Daniel?

Thank you, Jonathan, and thank you all for joining us today. As mentioned in our press release this afternoon, over the recent weeks, DBV has been having ongoing conversations and exchanges with the FDA regarding elements of our BLA with the intention of ensuring a complete, efficient and timely review of our upcoming Biologics License Application, the BLA for the Viaskin Peanut patch in children aged 4 through 7 years of age.

These extensive detailed conversations with the FDA are the kind of exchanges a sponsor would anticipate following submission of a BLA. They have been especially valuable for a novel, unique and complex product like the Viaskin Peanut patch that requires a similarly unique and complex submission package. And to be clear, the FDA has not requested additional data. DBV and the FDA have collaborated through a series of iterative meetings, information exchanges and filings to the Viaskin Peanut IND. Through this process and based on its review, DBV received valuable actionable input from the FDA specific to the organization, mapping and formatting of existing data sets for the CMC section as well as biostatistical elements of the BLA.

To provide some context for these exchanges, as we all know, the Viaskin Peanut patch is a unique and first of its kind drug device combination, which will be reviewed and approved as a biologic and therefore, sits at the intersection of many steps of regulations. There is no analog for Viaskin Peanut. We have charted this regulatory path, working closely with the FDA along the way, and we're grateful for their feedback and interaction.

To give you an example, given the size and overall complexity of our submission, topics have been in part been focused on ensuring the completeness of the BLA as well as identifying and mapping the location of data within the BLA to help the agency with the efficiency of their review. We are grateful for the FDA's constructive engagement at this stage of the work and believe by taking the required time to incorporate their feedback, we will strengthen our BLA submission. We plan to submit our BLA in the third quarter this year. The -- sorry, I skipped the page of my script here. Sorry, my apologies.

The need for new treatments for children and families living with the daily burden of peanut allergies is significant, and we feel a profound responsibility to advance the Viaskin Peanut patch as thoughtfully and efficiently as possible. With this feedback in hand, I look forward to optimizing our BLA submission and moving with urgency towards our goal of bringing Viaskin Peanut patch to patients who need new treatment options. I'd be happy to talk to you more about the nature of the feedback we received from the agency and answer your questions. I'll now pass it on to the operator for the Q&A.

[Operator Instructions] Our first question today comes from Kristen Kluska of Cantor Fitzgerald.

So the things you mentioned today typically sound like the things that arise in the middle of a regulatory submission. So on one end, very good to kind of iron this out now versus have it delay things down the line. But I'm just curious why the level of conversations were so detailed at this stage before the formal submission. Is this in part based on the designations on hand you've seen? Or any color there would be really helpful.

No, absolutely. The conversations have been very rich with the agency for many months now. And when the complexity of the BLA, given the fact that, again, it has no analog became something that the agency want to make sure that their review is efficient. Then the dialogue started to make sure that everything that matters to the FDA was in the BLA. And importantly, easy for them to find.

You probably know that a lot of time is spent by the FDA trying to find documents in the BLA. And the idea here was to work with them to make sure all of it was structured, mapped and easy for them to find and to make sure it was complete. So you're correct. Typically, these conversations will take place post filing. We very much welcome the fact that we've had these conversations prior to filing. Did that answer your question, Kristen?

Yes. And then are these factors also going to play into your BLA filing for the 1- to 3-year-olds when that occurs? And are you -- is there any other feedback or things that you can collect that are going to help with that process so that once that one is in good shape, maybe the meetings subsequently with the FDA will have already occurred as part of this 4- to 7-year-old submission?

That's an excellent question. The answer is yes. We expect that the conversation we've had right now about how to build the best BLA for the FDA to be able to review it efficiently in a timely way is going to make us a lot smarter as we put together the BLA in 1- to 3-year olds. As you can appreciate, this is -- there's nothing that looks like our product. There's no analog. So we're doing this along the way here. So dialogue with the agency on 4- to 7-year-olds, obviously, will make us smarter and faster in putting the BLA together for the 1- to 3-year-olds.

Next, we'll hear from Sushila Hernandez of Kempen Investment Banking.

So do you still expect that the BLA may be eligible for priority review? Or what is your latest thinking here?

Yes, we are -- we have breakthrough -- thank you, Sushila, for your question. We have breakthrough designation and thus, we are eligible for priority review. Our plan is to ask for it. And obviously, the work that we're doing right now will make that under any time frame, the review by the agency to be facilitated. So our plan is to ask for it. As you know, we get the answer at day 60 post filing.

Okay. And then in terms of time lines for incorporating the feedback from the agency, will this be a matter of days or months to finalize it? Yes, is it something that you've already been working on and just cutting it close to your own deadline?

Yes. So we are pretty rigorous with Gantt charts and planning at DBV sort of an operational focus of us. So all of this feedback from the agency has been mapped out. A lot of it can be done in parallel, obviously. We will be filing in Q3. We have a very clear plan to get it done and a clear date in mind. At this point in time, we're guiding to Q3.

What I think anybody involved in filing a BLA can appreciate there's not only the changes the FDA is asking us to do, but there's a domino effect. We have to make sure that as we change something in one place in the BLA, another table or listing that essentially is connected to it will also be affected. So the element of QA/QC, if you make a change is significant. And then the e-publication of the BLA, just to go to the portal alone at the agency takes a few days given the size of the file and the need for all the proper firewalls here. So all that to say, all of that has been mapped out and can start it very closely.

Okay. And then there are no issues with the manufacturing sites that you've been contracted. It's really more about mapping out the information that you already have.

That's exactly it. The FDA has not received the BLA yet. So they want to make sure that once they do get the BLA, all the things that matter to them are there and that they can find them and find them easily, along as you can imagine, there's a number of sort of sister and domino documents that come with the BLA to make sure that it's easy to access for the FDA. Does this answer your question?

From LifeSci Capital, we have Sam Slutsky.

This is Gaurav on for Sam. Just a couple for me here. So can you give color on the specific feedback the FDA wants you to incorporate in the BLA filing for 4- to 7-year-olds that wasn't there prior? And then could their information request potentially change the interpretability of the clinical results?

Yes, great question. Let me start with the latter question. The answer is no, simply because the FDA has not seen the content of the BLA. So the questions we got from them and their suggestions are not reactions to data in the BLA and interpretation here. So no, the changes we're making are not meant to address observations about the content of the BLA, the interpretation of it. This is simply to make sure that all the data the FDA needs is structured in a way that's easy for them to review and easy for them to trace. So that's essentially the comments we got from them. So no, there is nothing in there that would impact -- at least they haven't reviewed the BLA. So none of the exchanges were about content or interpretability of the BLA. Is that helpful?

Okay. Yes, very helpful. And you answered my follow-up.

Happy to help.

[Operator Instructions]

We'll proceed with Jon Wolleben of Citizens JMP.

A couple for me. Just wondering, without knowing the true context or size of these changes, any chance that this could get pushed to 4Q? Or is this going to be relatively easy to maneuver through?

You asked whether or not it could go into 4Q. Is that your question?

Yes. Yes.

Sorry, I think you broke up there. The answer is no. I mean, obviously, we have to do the work. You never know what surprise could come along the way here, but we have been very precise in mapping out the work we need to do, what it means and our guidance is Q3.

Okay. And then with COMFORT Toddlers, you guys have been guiding to submission in second half of the year, 6-month study, and I don't think we've heard of enrollment completing there. So any update on COMFORT Toddlers enrollment and the time lines for that BLA submission?

Yes. COMFORT Toddlers is enrolling as planned, and our guidance remains for us to file the BLA in 1 to 3 before the end of this year. And conversations with the agency on how to think about that have been ongoing.

We have no further questions at this time. Daniel, back over to you for any additional or closing comments.

Okay. Well, thank you. This concludes our call this afternoon. Again, we're very pleased with the progress we've made. We are delighted with the feedback from the agency and remain very committed, obviously, to filing the product as soon as possible as to help transform the lives of children and families who live with the daily burden of peanut allergy. Thank you so much.

Welcome to the DBV Technologies Update Conference Call. [Operator Instructions] Please note this event is being recorded.

I would now like to turn the conference over to Jonathan Neely. Please go ahead, sir.

Thank you, operator. This afternoon, DBV Technologies issued a press release announcing positive top line results from its Phase III VITESSE clinical trial of the VIASKIN Peanut patch in children aged 4 to 7 years old. 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 the therapeutic potential of VIASKIN Peanut and EPIT, our clinical and regulatory development plans, the design of our anticipated clinical trials, the timing and results of interactions with regulatory agencies, plans and expectations with respect to the submission of BLAs to FDA, expectations around the BLA's potential eligibility for priority review, anticipated support for the BLA submission, the exercise by investors of certain warrants issued as part of the financing announced on March 27, 2025, and the anticipated use of proceeds. 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 Daniel Tassé, DBV's Chief Executive Officer; and Dr. Pharis Mohideen, Chief Medical Officer. Also joining today's call is Chief Financial Officer, Virginie Boucinha; and Kevin Trapp, our Chief Commercial Officer.

I will now pass the call over to Daniel. Daniel?

Thank you, Jonathan, and thank you all for joining us this afternoon for this very exciting development, positive top line results from our pivotal Phase III VITESSE clinical trial of the VIASKIN Peanut patch in children 4 to 7 years old.

I will begin with a few remarks before turning the call over to Pharis Mohideen, our Chief Medical Officer, to dive into the results in more detail. We will then wrap up and happily take your questions.

To repeat, I'm absolutely thrilled to announce positive top line results from our Phase III VITESSE trial. This is a transformative moment for DBV Technologies and most importantly, represents tremendous hope for the nearly 400,000 children in this age group living with peanut allergy in the United States.

Let me highlight the key takeaways from today's announcement.

Most importantly, we met our primary endpoint. The lower bound of the 95% confidence interval was 24.5%, substantially exceeding the FDA's prespecified threshold of 15%. Additionally, 46.6% of subjects treated with the VIASKIN Peanut patch met response criteria at 12 months, and that compared with 14.8% of subjects in the placebo arm. The treatment effect of 31.8% was highly statistically significant, the miniscule p-value well below 0.00001.

Additionally, the data suggests the VIASKIN Peanut patch was safe and well tolerated with safety results that were consistent with the safety profile we've observed in the VIASKIN Peanut clinical program to date, which, as you know, is considerable. These results bring us closer to providing a much-needed treatment option for children with peanut allergy to their families, if approved. And we look forward to submitting a BLA as planned in the first half of 2026 with a potential priority review given our Breakthrough designation.

Before moving on, let me briefly address our financial position. In March of this year, we completed a financing of up to EUR 284.5 million. This included EUR 116.3 million received upfront with a potential additional aggregate of up to EUR 168.2 million in gross proceeds to receive, but the financing rate it warrants are all exercised.

Recall that the terms of the financing provided the exercise period of these warrants is accelerated upon the announcement of positive VITESSE top line results. And thus, as a result of today's announcement, the warrants are exercisable through January 15, 2026, which is 30 days following today's announcement.

Assuming all warrants are exercised, we believe that DBV will be sufficiently funded through the expected BLA submission for VIASKIN Peanut patch in 4- to 7-year-olds and through commercial launch, if approved.

And with that overview, I'll turn the call over to Pharis to discuss the detailed clinical results. Pharis?

Thank you, Daniel, and good afternoon, everyone. Today, we will present top line data. As you're aware, we will review and analyze the full data set as a standard practice and look forward to presenting the full results at upcoming medical meetings as well as publication in a peer-reviewed medical journal.

Now for the results. Let's start with the primary endpoint. The results are compelling. As Daniel mentioned, 46.6% of subjects treated with VIASKIN Peanut met the responder criteria at 12 months compared to 14.8% of subjects in the placebo arm. Critically, the lower bound of the 95% confidence interval was 24.5%, well exceeding the FDA's prespecified threshold of 15%, meeting the primary endpoint and giving us a clear regulatory path to BLA submission in the first half of next year.

The treatment difference of 31.8 percentage points is highly statistically significant with an exceedingly small p-value. This treatment effect is consistent with the treatment effect observed in our Phase III EPITOPE study of VIASKIN Peanut in 1- to 3-year olds, which was 33.4%. So it's reassuring to see the consistency of the VIASKIN Peanut treatment effect across the 1- to 7-year-old age range.

As you'll recall, VITESSE was originally designed to enroll 600 subjects. However, due to tremendous interest from families and investigators, we exceeded our target by enrolling 654 subjects. This makes VITESSE the largest immunotherapy clinical trial ever conducted in food allergy.

Now let me provide a brief reminder of the study design. VITESSE was designed to target a younger, more sensitive patient population of children aged 4 to 7 years with an entry eliciting dose for the food challenge of 100 milligrams. As we've seen in our prior clinical trials, these are the patients with a very high unmet medical need and who have experienced robust treatment effects with VIASKIN Peanut. The responder definition was designed to capture clinically meaningful increases in desensitization that would reduce the risk of an allergic reaction from accidental peanut consumption.

Recall that we changed our responder criteria relative to our previous studies to align with a younger, more sensitive target patient population. A treatment responder was defined as a subject with a baseline eliciting dose of less than or equal to 30 milligrams, reaching greater than or equal to 300 milligrams at month 12; or a subject with a baseline eliciting dose of 100 milligrams, reaching greater than or equal to 600 milligrams at month 12 as measured by double-blind, placebo-controlled food challenge.

The month 12 responder rates for the 1- to 30-milligram baseline eliciting dose stratum and the 100-milligram baseline eliciting dose stratum performed as expected based on our statistical projections from the 4- to 7-year-old subjects in our PEPITES 4- to 11-year-old study, and both beat the 15% lower bound of the 95% confidence interval.

The levels of desensitization we saw are highly clinically relevant. Studies of accidental peanut exposures show that the median amount consumed is 125 milligrams. So the results we are achieving with VIASKIN Peanut in the study are well above what children might typically encounter in real-world accidental exposures.

As mentioned, I'm very pleased to report that VIASKIN Peanut was well tolerated by participants in this trial, and the safety results were consistent with the safety profile of VIASKIN Peanut that we've observed in our prior clinical studies, which now encompasses over 1,600 patients and more than 1.1 million patch applications.

The most common treatment-emergent adverse events observed during the VITESSE study were mild to moderate local skin reactions at the patch application site. Discontinuations due to treatment-emergent adverse events were low at 3.2% in the treatment arm compared to 0.5% in the placebo arm.

Notably, there were no reports of treatment-related serious adverse events. And treatment-related anaphylaxis was low at 0.5% for just 2 subjects. Neither case of anaphylaxis resulted in treatment discontinuations. Overall, study compliance was high at 96.2% and consistent with what we have observed in other Phase III VIASKIN Peanut studies.

Adhesion data were collected throughout the study using a more robust collection methodology relative to previous studies. The data from this exploratory assessment were in line with the company's expectations.

Before I conclude, I would like to thank the patients and their families who participated in this study. Without them, none of this would have been possible.

I also need to thank the study centers. This was a very large study, and our centers really came through for us in recruitment and high-quality execution of the study protocol. To everyone who contributed to the study, thank you for your support and participation.

Now I'd like to turn the call back over to Daniel. Daniel?

Thank you, Pharis. Before moving on, there is one final point I'd like to make. Rates of enrollment in the VITESSE open-label extension were in line with previous VIASKIN Phase III studies. This is important because based on those previous studies, we anticipate the response rate to increase over time, consistent with other forms of allergy immunotherapy. We're currently evaluating the long-term efficacy and safety in the VITESSE open-label extension study, and we look forward to presenting those results in the future.

Now today's positive VITESSE top line results paved the way for BLA submission for the 4- to 7-year-old age group, which is anticipated in the first half 2026, follow a potential U.S. launch subject to FDA approval.

Now for our other clinical indication in toddlers ages 1 to 3, we have positive Phase III data already published in the New England Journal of Medicine, and we're currently conducting the COMFORT Toddlers supplemental safety study to support a BLA submission, which is anticipated in the second half of 2026 under an accelerated approval pathway.

Together, these 2 products, if approved, could address approximately 670,000 children ages 1 to 7 with peanut allergy in the United States, representing a substantial commercial opportunity and more importantly, a chance to meaningfully improve the lives of children and families living with this condition.

Now to wrap things up and before opening up to questions, please let me summarize our key takeaways for today.

First, VITESSE met its primary endpoint with highly statistically significant results, giving us a clear path to BLA submission as planned in the first half of next year with the potential for priority review.

Second, the clinical meaningfulness of these results is clear with a favorable safety profile consistent with previous clinical trials. VIASKIN Peanut has the potential to be a treatment solution for the nearly 400,000 children ages 4 to 7 living with peanut allergies, if approved.

And lastly, today's announcement of the positive VITESSE top line results triggers an acceleration of the exercise period of warrants issued as part of our March financing. Recall that we received EUR 116.3 million upfront. We have the potential to receive up to an additional -- sorry, EUR 168.2 million if all warrants are exercised as a result of today's positive VITESSE results.

Needless to say, we are very excited to end the year with this positive announcement as we enter 2026. We continue to execute on key activities, including completing both BLA submissions, preparing inventory and advancing toward potential commercialization launch in 4- to 7-year olds.

I will now turn it over and to happily answer your questions. Operator?

[Operator Instructions] And our first question will come from Sam Slutsky with LifeSci Capital.

Congrats on the awesome update.

Thank you.

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?

I'll be happy to take a part of that and have Pharis answer what the labeling might be, which again, is a bit of a premature question because we actually don't know.

But no, the next steps are for us to file the BLA in the first half of this year. There's a lot of work to be done internally, obviously, in assembling the BLA. The dialogue with the FDA continues, continues to be fruitful. The key people we've been interacting with are still at the agency, which I think is important. And there is nothing gating our ability to file that the FDA owes us. It's up to us to do the work and file in a timely way.

As far as the label goes, Pharis, you might want to talk about the REMS and sort of claim structure? The absence of REMS claim structure.

Yes. So Sam, as far as the label, I think it's going to be very traditional. Obviously, we have to have those discussions with the FDA. And what I mean by that is the efficacy is really clear cut. We're well above the 15%. There's nothing controversial there. The safety, as we've described, is entirely consistent with what we've seen in the past. And we will obviously use some of our legacy data in the BLA.

We've talked about would the FDA or other regulatory bodies want to put some sort of a REMS on this. And as we've talked about internally and externally, we can't think of what you would REMS -- I don't know if that's a real word, but because, again, put the patch on and you go about your daily living, and there's no real criteria that we could add to a label that would improve the use of the product from a safety standpoint.

And to be clear, as we've said before, the FDA has not identified a safety signal to date. We don't expect them to see one. So I think the label from my viewpoint right now, again, a little premature, but I think it will be very traditional efficacy safety as it's so clear cut.

Got it. Okay. And just jumping over to actually the 1- to 3-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?

Pharis, do you want to take that one?

Sure. Yes. So we're tracking exactly as scheduled. As you know, we have to go through each of the different regions and their regulatory bodies that's tracking as planned. For the sites that have already opened and are recruiting, they're doing well. So we're really pleased with the progress that we're making on the 1- to 3-year-old front.

And our next question will come from Jon Wolleben with Citizens.

Congrats on the data. Long time coming.

Thank you.

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 kind of ending cumulative eliciting or reactive dose that you saw for VIASKIN Peanut.

So Pharis, why don't you take the clinical relevance as a clinical regulatory matter, then I'll have maybe Kevin add some comments on the commercial front.

Yes, sure. As far as the primary endpoint, Jonathan, yes, it's absolutely highly clinically relevant. What we have to remember is the first year efficacy is an FDA statistical endpoint, right? And we clearly passed that. And as we've discussed in the past, allergen immunotherapy is a 3- to 5-year endeavor, right?

And so this is where shared decision-making comes in for families and the allergists making these longer-term decisions. And we believe that we check sort of the 3 major boxes of efficacy, safety, ease of use. And as we've said in the past, and as you've seen, we have long-term 3-year data where year 2 is better than year 1, year 3 is better than year 2. So we're really happy with where we are as far as the clinical relevance and where this fits into the treatment paradigm. And your second question was related to the cumulative reactive dose, is that correct?

Cumulative reactive dose, yes.

Yes. So again, this is top line data limited to the top line output as is normally the case when you do top line for a study. Obviously, we're going to get the full tables and listings, and we'll be presenting a lot more as we go through the full data set in the coming weeks to 2 months, and we'll present at congresses as well as published in a peer-reviewed journal. Does that answer your question, Jonathan, just to be clear?

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 1 year and older for multiple food allergies. Like how do you think about the addressable population for VIASKIN Peanut?

Yes. Let me kick that off, and I'll hand over to either Pharis or Kevin to add here. So there's only us as the best option, we believe, for desensitization, which is what parents want.

Many of the kids we see in our studies, I don't know what the results are in this study, but historically, it's been 60%, 65% of our children were multi-allergic. That being said, we have no problem recruiting patients, although we're only offering a solution for peanut. And the reason for that, and I'm sure Kevin can add to what he picks up in market research, is peanut is the big risk.

Peanuts are ubiquitous. The reaction is unpredictable. They can be quite violent and quite serious, and parents are perfectly happy to deal with peanut first and manage the rest of their kids allergies with vigilance and carrying an EpiPen.

The use of an IgE blocker in a population 1 to 7 is something that we don't see happening right now because the safety of blocking IgE production in the immune system in a chronic way has not been established. Moreover, needles and pain is an issue also in that population. So we like where we are. We think we're a product that is going to be, by far, the preferred choice when it comes to desensitizing kids. Anything you want to add about that, Kevin?

Yes. No, I think you said it. I mean there's no desensitizing multi-allergen FDA-approved treatment. So the desensitization factor here is important. And as Daniel said, we've done a number of studies in market research where parents are very concerned about peanut. And if we can just take that away, it's just a big relief. And that's really what we'll focus on.

I think it was a bit of a surprise in the market research that even kids on, who have multiple allergies, wanted to really take care of peanut. So that's what we'll focus on. We're certainly doing more work on segmentation, Jon, and we'll continue to look at that as we've got the profile here out of the test, which we're very excited about.

And we'll move next to Yatin Suneja with Guggenheim.

Congratulations. Very good results.

Thank you.

Just a couple for me. So the data look pretty much in line to what you have generated in Toddlers if you look at the younger patients. So the question is, have you looked at the breakdown between 4 to 5 versus 6 to 7 years old in this study?

And again, in that context, look, if the data continue to look pretty similar across 1 to 7, can you just talk about the TPP? I assume like the TPP for the toddler should be similar to the 4 to 7 as well, just put that in context?

Yes. Before Pharis adds here, yes, to make a key observation, the treatment effect was 31.8% in active in placebo and 4 to 7. It was 33.4% in 1 to 3. So that's pretty telling. And we're pretty pleased to see if that's rather remarkable the treatment effect is the same across 1 to 7 in the clinical study. So Pharis, anything you want to add about the data cuts of -- by age group, data that we have, and we'll be sharing later on?

Yes. So Yatin, we will definitely look at a lot of different parameters along those lines. Right now, we are focusing just on top line results.

And I think the key point here is what Daniel said, the treatment effect across the 1- to 7-year-old age range is just remarkably consistent. And it really is unbelievably consistent from that standpoint. So we can look forward to seeing more data cuts in the future. But right now, we're just focused on top line.

One more question if I may. One more question, if I may. Can you just talk about the duration of treatment? What is your expectations of resolution or kids growing out of allergy or your ability to sensitize them? And how should we think about that as we sort of model it? And then if you can comment anything on the pricing, given that this data continue to look pretty solid, like how should we -- or what is your research suggesting?

So Pharis, maybe what you're hearing from treating physicians about duration of treatment and then Kevin, what you're picking up in talking to the families?

Yes. So what we hear is that all allergen immunotherapies tend to be 3 to 5 years duration of treatment, and VIASKIN Peanut would definitely fall into that category. Longer durations of treatment, you tend to have better efficacy response.

In terms of resolution, there is sustained unresponsiveness data that we've generated in the past that is highly suggestive that there could be resolution. But obviously, that's not the primary endpoint of this study. We do have a 3-year open-label extension that Daniel mentioned, and that will give us a lot of insight into longer-term effects of VIASKIN Peanut. And we don't have resolution data coming right now at year 1, obviously. But we, like I said, do have some generated data in the past.

Kevin, anything to add?

Yes, I would just want to add -- I'd just add, I mean, I think this is a product where parents want to see it through the desensitization. I think given the 3 elements we've talked about of efficacy, the safety profile of this and the ease of use, it's something that does fit into their daily routines.

And as Pharis said, we've seen high retention into the open-label extension. So they do see it as allergy immunotherapies have been for decades, a 3- to 5-year treatment. They know what they're signing up for, and it fits into their life to be able to take peanut off the table, if you will. I mean what happens after that 3-year period in terms of introducing food or continuing with the product, I think that's up to an individual family. But the profile that's emerged here is very good.

And I'll bridge to the pricing question, Yatin, is we're doing the work. I think that's always subject to final label. So we've got to wait a little bit on that. And -- but we're out talking to payers now, and we've heard nothing but this is a category that they're not managing a lot. And I think we feel good that the product profile that comes out here will be consistent with what we've seen in other food allergy data points that are in the market. Does that answer your question?

Yes, very good.

[Operator Instructions] And we'll move to Kristen Kluska with Cantor.

Congrats on the data and great day for the peanut allergy community. Long time coming for them. So given that you enrolled a more sensitive group at baseline, curious how you're thinking about the percent of patients that will ultimately benefit recognizing that what is meaningful for each of them are going to differ based on where they start in a real-world setting, factoring the fact that patients will also likely be on the product for over 12 months as well.

So Pharis, why don't give a clinical perspective on this and maybe, Kevin, a commercial one?

Yes. So we targeted the younger, more sensitive patients because we felt there was the highest unmet medical need. But this is definitely generalizable to the larger 4- to 7-year-old indication. Remember, we did have a higher threshold of 300 milligrams in our other studies. And as you said, it's individualized to each family's needs and once from a therapy. And that's where the shared decision-making process comes into play, right?

And what we've heard from our sites and investigators is for families that want to know, okay, how much can my son or daughter tolerate? They can do what's called an open clinical food challenge where maybe you don't push them to near anaphylactic reactions, but you just see, hey, can they consume half a peanut, 1 peanut, 2 peanuts. And so it's very generalizable. And again, we work very closely with our allergists, and that's our prescribing base as we move forward. So we're very comfortable that this data is very much generalizable to the overall 4- to 7-year-old peanut population.

Yes. I'd just add commercial, Kristen. Let me just add commercially. I mean you're not going to typically do the food challenge at entry. You're going to find out through skin test and that they're allergic. So as Pharis said earlier, 125 milligrams is that threshold where typically the median where allergic reactions happen. So we're able to take them up to 300 or 600 milligram in 2 endpoints, which are significant fold increases, certainly in the ultrasensitive, the 1 milligram to 30 milligram cohort. But those that are at 100 milligram are still under that threshold, and we're able to take them up to 600 milligram.

So you're not going to necessarily know those in clinical practice, but you know your child have an allergy that's either going to the ER has been diagnosed at the allergists. And I think these are very meaningful clinical results at year 1 that will typically get better in years 2 through 5.

Okay. And I recognize you might not have the answer to this question yet, but one other thing we've discussed at length is part of this product potential is that if patients do have allergic reactions to peanuts, potentially the VIASKIN could make the reaction a little bit less severe. So I'm curious if you looked at the allergic reactions that did occur from the ED testing in the VIASKIN group relative to placebo and if there were any differences, albeit all the patients were having reactions at that point, but if the levels or complexities behind them showed any differences.

Yes. I can take that one.

Yes, Pharis can answer that. Before you answer Pharis, but yes, Kristen, you make an important point where not only does ED go up, so that's protective because the dose that triggers allergic reaction goes up. But yes, we did publish that the severity of those symptoms when you do consume peanuts tends to be quite a bit less also. So there's 2 elements here of protection. I gather, Pharis, we picked that up -- we've collated the data in the study also.

Yes, that's correct. As Daniel said, in the 1- to 3-year-old data set that we published, we did see a decrease in the severity of the reactions, and we also observed that in the other study that we did in 4- to 11-year olds. We have assessed that not for the top line results. But as I said, as we move forward, analyzing the full data set, we'll definitely look at that and present as is appropriate at upcoming medical conferences and/or in peer-reviewed journals. And obviously, the expectation is that we'd see similar decreases in severity during the food challenge.

And we'll hear next from Andrew Fein with H.C. Wainwright.

This is [ Abbie ] on for Andrew. Congratulations on the readout. So my question is, while the study met its primary endpoint, we have heard from physicians that they were hoping for kind of a responder rate closer to 50% in the treatment group. Can you talk about how you expect allergists to contextualize this result clinically and whether there are specific subgroups or secondary analyses that you think will be most important in reinforcing the confidence in real-world use?

So Pharis, why don't you take it from a clinical perspective and Kevin, commercial?

Yes, sure. So [ Abbie ], remember, year 1 efficacy is an FDA statistical endpoint, and we clearly passed that, right? And allergen immunotherapy, not just VIASKIN Peanut, but allergen immunotherapy in general is at least a 3- to 5-year treatment period. And so shared decision-making between the allergists and the family really comes into play here for a longer-term therapy.

And what allergists and families are looking for products that are efficacious, safe and really easy to use, so they can stay on it for 3 to 5 years. And we believe VIASKIN Peanut has achieved those outcomes. And as we've talked about our longer-term data in the 1- to 11-year-old age range, we know that year 2 is better than year 1, year 3 is better than year 2. So we just have to be sure we take the longer-term big picture view of this.

Obviously, there will be a lot of secondary and exploratory and even [ post-hoc cuts ] of different efficacy parameters. And based on our extensive data from previous studies, we know that there are a lot of other clinically meaningful endpoints that don't get exactly captured in just the primary endpoint.

If you look at things like what percentage of patients had an eliciting dose that increased, right. If you live at 1 milligram, 3 milligrams, and you get to 100, 1/3 of a peanut kernel, that's absolutely clinically meaningful and can change lives, but it doesn't get captured as a regulatory type endpoint, right? So we'll have a lot of that data coming out in the near future. And Kevin, is there anything you want to add to that?

Yes. No, thanks for the question. I think it's an important one. I think these 3 elements we keep talking about, to me, VIASKIN checks all 3 boxes, and it addresses a significant unmet need the way other pediatric food allergy treatments don't.

And we know this from the market research we've conducted with hundreds of parents and allergists. And it suggests it fits nicely within their practice routines where there's no need for multiple office visits. And it easily fits in for their current appointments for asthma or eczema that are already scheduled. So it is that shared decision-making. And I think it's important that this is a product that meets the needs of a lot of families, and we're looking forward to, if approved, getting the communications out around this. Thanks for the question. Does that answer?

Yes. That's great. And then just one more, if I can. Just a clarifying question on the warrants. So I know you guys said on the call that the warrants exercise has not been triggered by this data. So -- but you said that it funds the 4 to 7 BLA and into launch and commercialization if approved. Does this also cover the 1 to 3 BLA and -- moving towards commercialization? Or would there need to be additional capital for the toddler age group?

Thanks for the question, [ Abbie ]. Well, for now, obviously, we want to make sure that the warrants are exercised. I think the economics make a lot of sense for them to be exercised, get that in. And that is sufficient for us to do the big, how should I say, bullish and full of energy launch that we want to have in 4- to 7-year-olds. Other capital needs will be addressed in due time. But right now, our focus is 4 to 7 and exercising those warrants.

And next, we'll hear from Sushila Hernandez with Kempen.

Congrats on the results. So on both [indiscernible] how do you foresee both [indiscernible] 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?

You broke up on the first half of your question, Sushila, be kind enough to repeat it? We got the second half on treatment compliance, but we missed the first half.

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?

Pharis?

Yes. So if I understood the question correctly, so it's the age of initiation. So 4 to 7, you would stay on that product. 1 to 3, you can stay on that product. You don't necessarily have to switch when you become 4 or 5 if you were initiated when you were age 1 or 2. Does that answer your question? I wasn't sure that I heard the question correctly, sorry.

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?

Yes. So the compliance rates are extraordinarily high, 96.2%. That's consistent with what we've seen in other studies. So compliance is really not an issue or challenge at all for these patients.

Improving the patient experience, I'm not sure what we would do in that sense because, again, we have no restrictions in our clinical trials. Patients put the patch on any time of day they want, morning, afternoon, evening, and they just get into a routine. There are no restrictions as far as the patient needs to sit still or anything like that. Obviously, they avoid peanut while they're on the product.

So from our standpoint, the product is very easy to use. And I think our longer-term enrollments in the 3-year to 5-year studies that we've done really are a testament that it's easy to use. It's pragmatic. The safety profile you've seen is very well tolerated. So we believe that it checks all 3 of those boxes, as Kevin said, efficacy, safety, practicality, ease of use.

And we have no further questions at this time. I'd like to turn the conference back to Daniel Tassé for any additional or closing remarks.

I want to thank everybody for joining us and again, congratulate the team at DBV who has worked so hard. This was a very large study. And without sites and patients participating, obviously, we would not have these good results to share with you today.

So I thank you all for attending today. And as always, we're always available for extending conversation in other forms if you wish to do so. I wish everybody a great evening and happy holidays [ if we not talk ]. Bye-bye.

And this concludes today's conference call. Thank you for attending.