DBV Technologies S.A.

Welcome to the DBV second quarter 2026 results and business update conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. 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.

This 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 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 age 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 VLA submission, continued constructive engagement with SVA, expanded the Viasc and Pinot Clinical Program, and strengthen the foundation required to become a commercial stage company. I'll start with the status of the BLA. As we shared two weeks ago, we continue to optimize our BLA submission for the Bioskin Peanut Patch in children age four through seven 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 Bioskin Peanut Patch. And let me reiterate, the FDA has not requested additional data. The work underway is focused on incorporating FDA 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 4-7 and we plan to submit an optimized BLA in the third quarter of 2026 to support an efficient FDA review. In addition to these conversations, our progress in the first half of 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 four main topics, the Comfort Toddler Study, the TESS, 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 bioskin peanut patch in toddlers aged one to three years. This is an important milestone as we look to progress this program. About the test, we presented new data from our phase three study in four to seven-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 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 VITAS 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 IAQI, the design elements for Thrive were presented by Dr. Kirsten Perrette who is the co-lead investigator along with Professor Gideon Lack. DRIVE is assessing the efficacy and safety of the via skin peanut patch in achieving ad lib consumption of dietary peanut in infants with peanut allergy aged six through 12 months following three to four years of treatment with the via skin 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 one to three-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 Fiocchi, a leading allergist and colleague, 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 Fiocchi data were collected in 2022 and 2023. These two independent datasets, collected approximately seven years apart, both point to a US pediatric peanut allergy prevalence of approximately 2%. The confidence intervals further support that conclusion. Boucinha reported a 95% confidence interval of 2% to 2.5%, which overlap with the estimates across each pediatric age group in the Fiocci 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 Fiocchi 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 healthcare 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 timeline. 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 how 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 and the potential Dvayeskin 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 of 2026 reinforced our conviction in DBV's future We are advancing our LEAD program in four to seven-year-olds towards BLA submission. We have closed recruitment for Comfort Toddler Supplemental Safety Study in one to three-year-olds. We are expanding our ViaSkin PNUC clinical program with a very important DRIVE study. We are funded into the third quarter of 2027 to support operations and commercial preparedness, including The investments across our core functions required to potentially launch and support the long-term success of the Viaskin peanut patch. Now we're doing all of this with a clear purpose to help children's families living with the daily burden of peanut allergy.

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

If you would like to ask a question, please press star one on your telephone keypad now. You will be placed into the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you would like to ask a question, please press star one on your phone now. And our first question comes from Yatin Suneja at Guggenheim.

Hey guys, thank you for taking my question and thank you for all the details. Very helpful. So just two quick questions for me. Yeah. First is with regard to the filing and the acceptance and the timelines around it. So what are your working assumption? Like how should we think about the acceptance timelines? Will this be a standard review or a priority review? And then with regard to the CMs, The readiness and commercial supply, are there any implication 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 timelines are we will be asking for priority 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 timelines are 60 days. We'll ask for priority review, which would be a six-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 not completed. We've had all their comments in the process of making the adjustments that they want here. So there's nothing that the agency has asked us to do that represents a change in any way, shape, or form to The way we will attach to the product and the way we will describe that in the module three, the CMC section of the BLA.

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

Yeah, there are discussions ongoing. It's in, 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 two gating items right now progressing in parallel.

Thank you very much. Thank you.

And our next question comes from Sushila Hernandez of VLK.

Yes. Thank you for taking my questions. I also have two. 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 on any other fronts?

Yeah. Okay.

So those are your two questions, Sheila?

Yes. So the short answer is yes. The dialogue with the agency is ongoing. When dialogue is both talking as well as exchanging emails. 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 try that answers the two half-series questions.

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

So, I just want to take that one. It's your baby.

So, with the, yeah, with the recruitment completed, oh, sorry, yeah, go ahead.

No, it's a six-month safety study. Again, there's no efficacy component to it. We did the food challenge up front to have increased excursion, but it's a six-month treatment period.

Okay, that's clear. Thank you.

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

Thanks so much for the updates. A couple questions for me. First, I think most of us on the line probably have never submitted an application before. So can you help us just to try to imagine what it's like to reformat things? You know, 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. Yeah, there's nothing you do in an office that looks like filing a BLA. This is not a zip file you attach to an email. 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 CFRs. 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. and all of 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 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 is 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 hope that answers your question here, but it's a massive undertaking. It's all about details.

Thank you so much for that additional caller. And then on comfort toddlers, 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?

Yeah, 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 four to seven. 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. Okay.

Thank you so much. Appreciate it. It did. Thank you.

Thank you.

And our next question comes from John Willeben of Citizens Capital.

Hey, thanks for taking the question. A couple on commercial from me. Do you guys have any sense of the average price of Xolair in one to 70-year-olds and what pricing band you guys have been testing with payers?

Kevin, you say that one? Yeah, sure. Yeah. As you know, I mean, Xolair is IG and weight-based, so it'll vary across that age range. We've seen prices from around 10,000 into the 30s, depending on that. We've tested a range of prices. We're not going to finalize anything yet. We've got payer discussions that'll be upcoming here in the next month, advisory boards. But the research is being done, and as we get tighter on this, we get closer 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 one to seven-year-olds with peanut allergy would seek some form of therapy? And then digging into that, who would be a likely candidate for Bioskin's peanut versus who would not be?

Yeah, we're working through the segment.

Yeah, sure. Yeah, I mean, look, we've done a lot of both parent research and allergist research. And, you know, I would say that we always see very significant demand as we talk to parents. and we know it's not it's not one market. So as we continue to look through segmentation and who will activate first, you know, 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, you know, there's a group that, you know, 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've 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. 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.

Candor is wonderful. Thanks, John.

As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. and our next question comes from Sam Sletsky of LifeSci Capital.

Hey, good evening. Appreciate the question. 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 and I can answer it.

So this is a phase two study. It's really almost more of a proof of concept study, Sam. So the objective, and this is sort of trampolining off of the one to three-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 if These 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? That'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 one thing, Faris, if I may. What's not changing here is what is the duration of treatment, right? We expect kids will be on therapy for three, four, five years. We're trying to do the same thing here in six to 12 month olds. So we could have decided to do this study as part of a phase four 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 is going to show some benefits here. That's why we're calling it phase two study. But it's a question that deserves to be answered, and it does not change the treatment paradigm of using glass skin peanut in toddlers who are peanut allergic.

Okay, thanks. Is that helpful, Sam? Yeah? Yep. Thank you.

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 questions and transforming the lives of children's families living the 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.