DBV Technologies SA Sponsored ADR Aktie

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.

Good day, and welcome to the DBV Technologies Update Conference Call. [Operator Instructions] Please note, this event is being recorded. Now I'd like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

Thank you. This afternoon, DBV Technologies issued a press release announcing the initiation of the 6-month COMFORT Toddlers Safety study. This press release is available in the Press Releases section of the DBV Technologies website.

Before we begin, please note that today's call may include a number of forward-looking statements, including, but not limited to, comments regarding our clinical and regulatory development plans, the design of our anticipated clinical trials, the timing and results of interactions with regulatory agencies, our plans and expectations with respect to our clinical trials, plans with respect to submission BLAs to FDA, expectations with respect to any action or regulatory pathways, including an accelerated approval pathway, 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 Tasse, Chief Executive Officer of DBV; and Dr. Pharis Mohideen, our Chief Medical Officer. Also joining the call today is DBV's Chief Financial Officer, Virginie Boucinha.

I will now pass the call over to Daniel.

Thank you, Katie, and thank you all for joining us on this call this afternoon. I am thrilled to announce today the initiation of COMFORT Toddlers, which, as you may recall, is a 6-month supplemental safety study that is the final piece required to support a BLA, seeking regulatory approval of the Viaskin Peanut patch in toddlers ages 1 through 3 years old.

Data generated from COMFORT Toddlers, when combined with data from EPITOPE, our Phase III efficacy and safety study, will support the submission of a BLA, which is anticipated in the second half of 2026 under an accelerated approval pathway as previously agreed to with the FDA.

Screening our first patient brings us one step closer to delivering on our mission to bring this potentially groundbreaking therapy to peanut-allergic patients, and I'll let Pharis, whom and his team did such a fantastic job, provide you more details shortly. But suffice to say, there have been some exciting developments over the last couple of days.

Now for those of you who are new to our work, Viaskin Peanut is our novel approach to epicutaneous immunotherapy or EPIT. And as a reminder, the square patch for toddlers ages 1 to 3 and the circular patch for children ages 4 to 7 years of age are regarded by the FDA as separate product candidates, meaning that we plan to submit 2 BLAs, one for each age group in the second and the first half of 2026, respectively. We also have 2 distinct opportunities to help patients in need as well as opportunities in each of these BLAs to potentially create significant and enduring value for our company.

Now to be clear, we see a significant market opportunity in both age groups with approximately 280,000 toddlers aged 1 to 3 and around 390,000 children ages 4 through 7 living with peanut allergy in the U.S. alone.

Now we've talked a lot about 4 to 7 in the last few months, but today, I'd like to focus on the distinct opportunity with the toddler indication.

Now a quick key point I wish to make is that peanut allergy is often diagnosed early in life. Typically, within the first 3 years of life with many cases be identified even earlier as parents follow the early introduction guidelines. This represents a critical opportunity for intervention with immunotherapy. Upon confirmatory diagnosis of peanut allergy, parents are highly motivated to do something about their child's diagnosis, driven also by the vulnerability of the toddler who often can't yet communicate effectively and tend to explore the world orally. Understandably, this is a time when many families are especially eager to seek treatment.

Now 2 FDA-approved treatments for peanut allergies are now available and are welcome advancements for the food allergy community. But as allergists discuss the best treatment for their patients, consideration is given to, among other things, the developing immune systems of their very young patients, the time commitment required and the potential burden on the family as well as the nature of the drug's very clinical profile. As such, both we and the physicians we engage see a clear and ongoing need for additional treatment options, particularly a noninvasive treatment option such as Viaskin Peanut.

Another key point I wish to make is that early intervention with immunotherapy like Viaskin Peanut is key. Timing matters and data shows that the earlier you treat patients, the greater the potential benefit. Young immune systems are inherently more plastic, more adaptable and more receptive to reeducation through immunotherapy. We saw this clearly in our 12-month Phase III efficacy and safety study named EPITOPE, and this was further reinforced in the open-label extension as recently published in JACI: In Practice. We are seeing continued and growing interest in this area by physicians and allergists as we saw firsthand at the last [indiscernible] product theater, where once again, we had a record-breaking attendance.

Now with Viaskin Peanuts, we believe we can offer a practical solution that meets families' needs. Our market research consistently shows that caregivers and allergists evaluate therapies based on 3 key criteria: efficacy, safety and very importantly, particularly a pediatric population, ease of use. And with Viaskin Peanut, we believe that if approved, we will deliver on these 3 treatment goals.

Firstly, Viaskin Peanut offers a convenient, noninvasive approach that can be seamlessly integrated into daily life, requiring only the simple, easy, warm and loving application remove of the patch in the child's back each day. Importantly, in our clinical trials conducted to date, kids can be kids. You put the patch on, they go on with their daily lives. They chase their brother in the backyard, they play with the dog, they run around. They can be kids. There's no limitation on activities of daily living.

Secondly, we have seen consistently favorable safety and tolerability profile for Viaskin Peanut, supported by the data we generated in EPITOPE, our Phase III pivotal trial in toddlers. Furthermore, a statistically significant treatment effect after 12 months was demonstrated as we published in the New England Journal of Medicine in 2023, with even greater gains in desensitization seen through 3 years of treatment. These data are supportive of Viaskin Peanut's potential as a disease-modifying therapy with the potential to further enhance protection the longer patients remain on treatment. And with data suggesting compliance rates exceeding 95% in EPITOPE and no discontinuations due to adverse events, we believe the data does support Viaskin Peanut as a well-tolerated desensitization approach for toddlers.

So today's announcement of initiation of COMFORT Toddlers represents a meaningful step forward towards bringing Viaskin Peanut as a treatment option to peanut-allergic toddlers and to the families who urgently need more options for managing their child's peanut allergy.

And with that, let me hand the call over to Pharis Mohideen.

Thank you, Daniel. It may be helpful to review the toddler regulatory pathway. As you may recall that in December of last year, we reached agreement with the FDA on a formalized accelerated approval pathway for the Viaskin Peanut patch in toddlers. This marked a critical milestone, providing us with a clear and well-defined regulatory path forward. The BLA for the toddler indication will be supported by data from our Phase III efficacy and safety study, EPITOPE, which the FDA has already seen along with the recently initiated COMFORT Toddlers 6-month supplemental safety study. We anticipate submitting the toddler BLA under the accelerated approval pathway in the second half of next year. In parallel and in accordance with our alignment with the agency, we will initiate a post-marketing confirmatory study at the time of the toddler BLA submission as required under the accelerated approval framework.

I'm absolutely delighted to share that yesterday, our first patient for COMFORT Toddlers was screened at the Respiratory Medicine Research Institute of Michigan in Ann Arbor with Dr. Jeffrey Leflein as Principal Investigator. And just earlier today, 2 additional sites were activated with both sites now open for recruitment, one at the Allergy and Asthma Center in Maplewood, Minnesota, with Dr. Doug McMahon as Principal Investigator, and the second at Hamilton Allergy and Immunology Clinic in Ontario, Canada, with Dr. Jason Ohayon as Principal Investigator. This is fantastic news for DBV and all our stakeholders, but most importantly, for our patients and their families.

I welcome this opportunity to extend a heartfelt thank you to Dr. Jeffrey Leflein and his staff and of course, to the first patient enrolled in his or her family.

I'd also like to acknowledge the hard work of Doctors Doug McMahon and Jason Ohayon and their teams for getting their sites activated, plus all of our site investigators who have volunteered to be part of this pivotal study.

As previously announced, Dr. Julie Wang, President -- Professor of Pediatrics, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, will act as the Global Principal Investigator for the COMFORT Toddlers study, and we are honored to have her lead this pivotal study.

Let me briefly describe the COMFORT Toddlers study. This is a 6-month double-blind, placebo-controlled study designed to generate additional safety data for the Viaskin Peanut patch in peanut-allergic toddlers 1 to 3 years old as well as to collect patch wear time and adhesion data as exploratory assessments. To be very clear, the FDA did not identify any safety signals in the EPITOPE study and the request for the COMFORT Toddlers safety study is simply to meet the ICH guidelines to have close to 600 subjects exposed to treatment for at least 6 months.

Following the 6-month double-blind placebo-controlled period is an optional 18-month open-label treatment phase. This provides a total of 24 or 18 months of treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively. We anticipate that COMFORT Toddlers will enroll approximately 480 subjects randomized 3:1 active to placebo at approximately 80 to 90 study centers across the U.S., Canada, Australia and Europe. Key inclusion criteria include skin prick test, peanut-specific IgE and reaction following a double-blind, placebo-controlled food challenge to an eliciting dose of 300 milligrams or less of peanut protein. These are the same inclusion criteria used in the EPITOPE study.

In preparation for the initiation of COMFORT Toddlers, we held our North America investigator meeting in Atlanta, Georgia earlier this month. The meeting was met with great enthusiasm from our U.S. and Canada-based investigators. There were over 90 site staff in attendance, representing 45 sites. Investigators and clinical staff received comprehensive training on the study protocol, all key study-related procedures and where applicable, the relevant regulatory framework. It was a great kickoff for the study.

And just last week, we returned from EAACI, the European Academy of Allergy and Clinical Immunology Scientific Meeting in Glasgow. We had the opportunity to meet with many allergists and nearly all of our EU, Australia and U.K. site investigators. The excitement surrounding the trial was palpable, fueled in large part by the data generated in our EPITOPE study and more recently, the compelling data from year 2 of the open-label extension of EPITOPE. We look forward to initiating our sites in EU, Canada, the U.K. and Australia, where work already started several months ago.

Let me pivot and provide a quick update on our Viaskin Peanut program for children ages 4 to 7 years old using the circular patch. As we announced in March of this year, the BLA will consist of the ongoing fully enrolled VITESSE Phase III trial. The FDA confirmed that safety exposure data generated from the VITESSE trial, together with the VITESSE open-label extension are sufficient to support a BLA for the Viaskin Peanut patch in children 4 to 7 years old. So while we originally plan to run a supplemental safety study in children 4 to 7 years old, similar to COMFORT Toddlers, such a study is no longer required.

As a reminder, VITESSE is a large pediatric study, in fact, the largest food allergy study conducted to date in this age group. We had originally planned to enroll 600 subjects, but due to tremendous interest, we enrolled a total of 654 subjects across 86 sites in the U.S., Canada, Europe, the U.K. and Australia. The test continues to progress very nicely, and we anticipate reporting top line data in the fourth quarter of this year with the expectation to submit a BLA for the 4- to 7-year olds in the first half of next year. Recall that this is about a year earlier than previously anticipated. It's worth noting that Viaskin Peanut has been given breakthrough designation by FDA, so the BLA for this product may be eligible for priority review.

Well, that concludes my update. At this point, I'll turn it back to Daniel.

Thank you, Pharis. 2025 at DBV will all be about execution. We are now well underway with both of our core clinical programs as we prepare for VITESSE top line data later this year, as Pharis mentioned, and are making headway with COMFORT Toddlers. Our first patient COMFORT Toddlers this week marks a crucial step forward in our mission to develop this potentially drug-breaking therapy and are excited to get this study initiated. Patients and families are counting on us at that symbol.

We're also well positioned to fund these initiatives, having recently completed an important and timely financing of up to $306.9 million, including $125.5 million received upfront. BLA preparation is now fully underway with the regulatory team actively progressing both dossiers in parallel. At the same time, we are decisively transitioning DBV into a commercial stage company, ramping up pre-commercial activities and getting ready to launch. With 2 BLA submissions planned for 2026, we believe we now have a clear line of sight to potential commercialization and thus, exciting times lie ahead for us.

Now before opening the call to your questions, I would like to briefly recap, as Pharis mentioned, our significant participation at this year's European Academy of Allergy and Clinical Immunology Congress 2025, which was held just a few weeks ago in Glasgow, Scotland. The EAACI Congress, as it is known, is among the most prestigious and widely attended gatherings of allergy experts and thought leaders from around the world. The speakers for DBV symposium were among the top experts in the field, including doctors: Professor Gideon Lack, Alexandra Santos and Katharina Blumchen.

The symposium featured [indiscernible] on the important patient allergist clinical relationship, what is known as a care decision-making, a big part of how treatment is initiated immunotherapy as well as new clinical data on epicutaneous immunotherapy for peanut allergy. Other highlights included new clinical data from year 2 EPITOPE, the open-label extension, which was presented by Dr. Jay Lieberman, and the data suggests further reductions in accidental peanut consumption-related reactions with increased time on treatment, reinforcing the potential of Viaskin Peanut to mitigate reactions in toddlers due to accidental peanut consumption, which we know are way too common despite families practicing strict avoidance. In essence, that's quite simply what we aim to do with Viaskin Peanut.

This concludes our prepared remarks. I want to thank everyone on the phone and on the webcast for joining us today. I now ask Pharis to join me for Q&A.

[Operator Instructions] Our first question comes from Jon Wolleben of Citizens Bank.

Congrats on the progress. I got a few initially on kind of enrollment expectations and then a follow-up. But I was hoping you could tell us a little bit about differences in inclusion/exclusion criteria between COMFORT Toddlers and EPITOPE and remind us what the screen failure look like there, if there's any learnings and what gives you confidence that you can hit timing given the inclusion of a food challenge in these young kids?

Great question. Pharis, do you want to take that one?

Yes, sure. Jon, in terms of the enrollment criteria, they're the same for COMFORT Toddlers as they are in EPITOPE. And that's 100% by design. We wanted to have the same patient population recruited so that when we compile the BLA, we won't have 2 disparate patient populations. But that's exactly the same. So the IgE, the skinfold test, the food challenge inclusion criteria match up between the 2 studies.

And then in terms of having the food challenge, as we've said in the past, the 1- to 3-year olds, many of our sites actually feel that they're a lot easier to do food challenges on because they don't have that psychological overlay of remembering what an anaphylactic reaction felt like, they kind of just gobble down the food challenge material. So from that standpoint, we don't think that will be a significant hindrance to recruitment at all.

And then in terms of the screen failure rate, you may be alluding to the screen failure rate in EPITOPE and the time it took to recruit that. But we have to remember that a lot of that recruitment took place during the time of the COVID pandemic, which fortunately we're not in for the COMFORT Toddlers study. So we expect to have screen failure rates that are historically similar to what we've had in previous trials, no higher than that. And again, as we've mentioned, we'll have 80 to 90 sites spread out globally. So I'm very confident that we can hit our time lines and stick to what we've said in the past.

Sorry. I was going to add, Jon, if I may, to be helpful here. Not only was EPITOPE run during the pandemic, but on top of it, was at a time where we didn't have any data in the benefit of Viaskin Peanut. It was not much known in the older kids. We had nothing in 1 to 3. So a complete different dynamic right now of allergists, and I would argue parents also through the help of patient advocacy groups, much better understand that there's a real benefit to be at least tested or postulated in 1- to 3-year old. So 480 patients is a large study. But again, Pharis and his team are very good at what they do. We don't believe the food challenge is going to be a major barrier. And the momentum we have out of the gate for COMFORT Toddlers is completely different than what we had way back when with EPITOPE. So we are quite confident we can enroll this patient -- this study quickly, but it's a big study.

And looking down the road, I don't think you guys have talked about this much, but what would a confirmatory trial look like? Because about a year from now, you have to have that up and running. So can you talk a little bit about that design?

Sure. So in broad strokes, it will look very similar to the EPITOPE study, a 12-month efficacy study with a double-blind placebo-controlled food challenges in the similar same patient population. So broad strokes, we have had the discussion with the agency, and we know that it will be a 12-month efficacy type study. I would imagine it's going to be almost identical to EPITOPE.

Our next question comes from Sam Slutsky of LifeSci Capital.

Just I'm curious how you guys are thinking about success in COMFORT Toddlers in terms of what you want to see there for that, I guess, both from an FDA perspective as well as just your own interpretation of the data? And then how important are the 6-month initial data versus some of the open-label extension data for the FDA?

Again, let's Pharis answer. This is a [indiscernible].

Yes. In terms of the data, Sam, we expect to see what we've seen in the past. And what we've seen is just an incredibly consistent safety profile. Again, the intent here is to get our exposure numbers close to 600. There's no specific safety signal that the FDA has asked us to investigate. So I fully expect to see no surprises and to have consistency with what we've seen previously from our close to 2,000 patients that have worn the patch. And in terms of the 6-month versus the open-label extension, the FDA is interested in the 6-month data. As you know, and as we've discussed in the past multiple times, we have a product that can be worn for many years. And we believe that it's important to offer the product for multiple years beyond the 6 months. So we voluntarily do the open-label extensions to be able to generate more data to give our potential future prescribers if were approved, a lot of data to discuss with families. And so the OLE part is voluntary, but we think it only helps to profile and characterize the product better.

Got it. Okay. And then just jumping to the tests real quick. Just assuming obviously a positive outcome later this year, can you just walk through how you're thinking about pre-commercialization prep and then expectations on distribution, whether that be specialty pharmacy or some other path?

I'll take that one, Sam. The commercialization, obviously, we have to start planning that right now. As we all know, you don't launch a product with only 3 or 6 months of preparation, everything from market segmentation to testing pricing corridors, distribution strategies have to be explored and thought through here. We have not finalized any distribution model. A specialty pharmacy is obviously attractive given the fact that although it's a very large market, we'll have tens of thousands -- hundreds of thousands of patients on therapy if things go as planned. There's an element of intimacy between DBV and the family, questions, these cases -- these patients obviously are sometimes of some complexity given the fact that peanut might not be their only allergy. So we like the specialty distribution model for that reason. It provides just better exchange between the parents and the therapy, but those decisions are not finalized yet. It's all part of what we'll be assessing between now and launch time, which is not that far away. So hopefully, that answers your question.

[Operator Instructions] We have no questions at this time. Daniel, I'll turn the conference back over to you for any additional or closing remarks.

Thank you so much. Thank you, operator, and thank you all for taking the time to join our call this afternoon. Initiation of COMFORT Toddlers was a big deal for us, obviously, because a significant milestone in the continuous advancement of this program. While the upcoming data, VITESSE Phase III in 4- to 7-year old in the last quarter of the year, if positive, will be the last piece for supporting, obviously, BLA in that population. So '25 is the execution of clinical trials. When you think of the execution, putting BLAs together and taking them to the agency. But after many, many years of hard work, this is where we want it to be. And I certainly want to reassure anybody who's a stakeholder at DBV that the team is working hard with a great sense of mission and pride, and we'll keep you posted, obviously, of the next chapters in our progress. I thank you again all and wish you a very good evening.