Hey, good afternoon, everybody. Thanks for joining us for day one of the Citizens Life Sciences Conference. My name is Jonathan Wolleben, Senior Analyst here, and I'm pleased to have DBV Technologies joining us, represented today with CFO, Virginie Boucinha, and Chief Commercial Officer, Kevin Trapp. Thanks for joining us today, guys.
Thank you.
Yeah, thanks for having us.
We've been tracking the space and the company for quite some time, but for those who aren't as familiar with the story, can you tell us what are you guys working on at DBV?
Sure, yeah. Thanks for having us, Jonathan. DBV is a French-based company. The founders started there, and we're a late-stage biotechnology company focused on transforming the lives of people with food allergies. Food allergy is an area that's somewhat been underdeveloped in the pharmaceutical industry. There's significant unmet needs in this population, quality of life issues, healthcare costs, and obviously there's the potential for allergic reactions that can be life-threatening. Our focus is leveraging our breakthrough platform of epicutaneous immunotherapy that we call VIASKIN, so via the skin, to apply small amounts of allergen to the skin that are picked up by antigen-presenting cells, carried to the local lymph nodes and then presented through Tregs to help tamp down and protect against allergic reactions to truly desensitize.
That's the focus of the platform. We're looking at that first and foremost in peanut allergy, given the significance of that allergen, it's ubiquitous in society, and we've seen, you know, a lot of unmet need. Patients typically don't grow out of that. 80% of the time, they have it for life. Our focus has been on younger children. We have two BLAs that we plan to submit in 2026. The first is in the 4-year to 7-year-old age category that will be submitted in the first half of this year and following that in the 1-year to 3-year-old age category. I would say looking at peanut allergy, the focus here is treating early.
I would think a lot of the policy agenda right now, the medical society is looking at both introducing foods earlier, so we've seen the food guidelines move to earlier ages, therefore the peanut allergy will be diagnosed earlier and you can treat earlier. We believe we've got a product that delivers on all of the unmet needs for the youngest children with both efficacy, safety and practicality.
This has been a winding story to say the least, with lots of twists and turns, a lot on the regulatory front. I think, you know, the real turning point was probably the phase III data you guys had in 1-year or 3-year-olds a couple of years ago. Just last year you had another phase III success in 4-year to 7-year-olds that looked fantastic as well. Kevin, you mentioned the kinda two different BLAs. Virginie, maybe you could talk a little bit about, you know, why separate the two age groups and what that means from a development perspective.
Yes. Maybe I'll start with the 1-year to 3-year-olds and separate BLAs. They are considered as different products by the FDA, and it's an advantage for us. Not that the products are significantly different, but at the end of the day, it is two opportunities and two products to be put out on the market for us, and therefore not being merged together. For the 1-year to 3-year-olds, we are nearly there in terms of development and regulatory pathway.
We have an accelerated approval pathway for the BLA in toddlers for one to three that is based and will be nurtured by data that was from our phase III efficacy and safety clinical study, EPITOPE study, which is already with the FDA, and we are currently conducting a COMFORT 6-month safety study, which will be the last piece for us to support the BLA filing in the current year. In terms of BLA and maybe in terms of clinical milestones, I think it's important for us to have this perspective. We are happy to have a very rich agenda of clinical milestones ahead of us for the next 18 months. We will be having a BLA acceptance for the 4 years to 7 years old.
We will be completing the COMFORT study I just mentioned. We will be also having a BLA submission for the one to three, a BLA approval for the 4 year-7 years olds, eventually be launching for 4 years-7 years olds, BLA, and then on the other age, being approved in the 1 year-3 years olds and launching in the 1 year-3 years old. That's a rich agenda ahead of us for 18 months.
Since we have the two different age groups, let's treat them kinda differently for discussion's sake. Where do you guys wanna go first, four to seven or one to three?
Treating earlier is better.
So maybe-
The average age of diagnosis I said is two, but you see that distribution. We see kinda 1-7 as the window of opportunity where you see the most profound benefit of immunotherapy, so the ability to desensitize to raise the child's tolerance level, and potentially to disease modify at that age level. All immunotherapies that are used in food allergy, you see a better effect the earlier you go. I think the reason I say, you know, earlier, we also have a product that meets the needs of that market. It's non-invasive. You don't have to ingest the oral protein, and you don't have to take a needle. It's
Mm-hmm.
It fits a lot of the needs there. I'd say 1-3 because it's earlier and there's a better chance of desensitization.
Yeah.
I would say our treatment effects across all of our studies have been remarkably similar as we look at this 1-7 age category.
Your studies were designed to show kind of a response rate, which is sometimes kinda hard to wrap your head around if you're not in the weeds.
Yeah.
Tell us about what you've shown in your clinical trials that give you confidence that VIASKIN Peanut's working.
Just for context, we've had over 1,600 patients treated with VIASKIN Peanut, and over 1.1 million patch years. We've been at this for a little while, as Jonathan alluded to in the beginning. This is one year efficacy, and what we saw in VITESSE was 47% in the active arm, a responder. That's the one year FDA criteria, so this was at 300 mg, which is roughly a peanut, or 600 mg, which would be two peanuts, versus 15% in placebo. Very statistically significant. I think it was seventeen zeros and a one. Most importantly, meeting the lower bound of confidence that the FDA sets at 15%, and we beat that by a large margin.
That's the 1 year treatment effect for FDA at 1 year. What we see in this, we do open-label extensions out to 3 to 5 years in all of our studies, and we see this gets progressively better as you continue to treat. I'd say one other thing that we just presented at AAAAI was these are the thresholds for endpoints, but we looked at the VITESSE data for who moved up one threshold of ingesting peanuts. Going from 10 mg to 30 mg, which confers a lot of risk reduction for the child. We saw five out of six kids in the active arm responded to that or had a positive eliciting dose response. Importantly, when we looked at the placebo, 1 out of 4 children actually became more sensitive to peanut.
Not treating and not treating early has a significant impact on tolerance.
Interesting thought here, Kevin. When you're gonna be launching a product, hopefully, who's the audience here when you're messaging VIASKIN Peanut? Is it the allergist or the family? 'Cause this is such a well-
Yeah.
Like, if you have peanut allergy, it's affecting your family. Like, you wanna get something done.
Yeah.
How well do they understand kind of these response rates, or how do you communicate to maybe two different audiences?
Yeah. I think, you know, the parent will obviously be very important as we launch this and their education. This is a parent cohort as we've talked to them, that is significantly online researching this. They understand a lot of it, but it will be our job to communicate this in layman's terms and make sure they understand it. Raising thresholds is risk reduction. We've also seen a decline in severity in our studies, so if they had a major reaction before, it's possible to be lesser the next time. We've looked at data on that, and we've published some of that. There's kind of that dual benefit of raising the threshold for protection, reducing the severity of the illness. Allergists will certainly be a key part of this.
We see them as the primary writer of this at launch. They have about six out of 10 kids that are in our prevalent population now, so they're already in there with visits. We'll also have an active campaign to pediatricians through non-personal promotion.
Virginie, we mentioned epicutaneous immunotherapy, but logistically, what does it look like? Like, what is the daily administration? Like, what's the process of treating?
So-
This is different than a typical therapeutic.
It will be different. The promise and the way we VIASKIN Peanut and VIASKIN works, and the principle is to retrain the immune system in the body by administering on a daily basis through the lymphatic system, a minuscule dose of the protein we are trying to address. Here, it's the peanut protein, and by doing so on a daily basis via skin, so via a patch which we apply between the children shoulder blades on a daily basis, we basically train the immune system daily to recognize this protein and to lessen over time the reaction of the children that are treated. That's a very novel or that's a very interesting alternative way of treating because our promise here is desensitization.
There are other alternatives where we suppress the immune response of the body, specifically OIT, but in our case, we are desensitizing, reducing the reaction to the allergen again, so that over time, and that's very important to parents and caregivers, the reaction to an accidental exposure or to an exposure on a daily life is not as life-threatening as it is without desensitization therapy. That's our promise.
You know, an interesting dynamic here is if, you know, the other common way to treat food allergy is with oral immunotherapy. You give someone a little bit of what they're allergic to. If you're doing that, you know what you can tolerate. With a patch, how do we know it's working?
Yeah. Well, I think there's a number of things. One, I think the clinical data speaks for itself that it is working very well. I think what we'll see is over the three years of therapy or three to five years of therapy, whatever the parent decides with the allergist, which called shared decision-making, they'll decide. At the end of those three years, do they wanna actually ingest the food and see where they stand in terms of the eliciting dose? There are also a number of biomarkers around, along the way that we've looked at. IgE typically goes up as you start the patch and then comes down, and IgG4 goes up. So there's visits like that where they can check in on that.
I mean, ultimately, it'll be hopefully you're reducing the number of allergic reactions, so they're not seeing a lot of use of rescue medications and things along those lines.
Where the rubber meets the road.
Yeah. Yeah, exactly.
What about safety?
Safety, we've seen a remarkably consistent safety profile, very low anaphylaxis rates in the tests. It was 0.5%, two children, both of them continued in the study. We see local site reactions. This is a skin patch applied to the back, so we'll see some of those, but they're all mild to moderate and typically resolve over the first few months, and you can use topical corticosteroids to manage any of the site reactions that may occur.
This has been an interesting dynamic market to think about because, you know, many years, everyone knows you can't get peanuts on an airplane now.
Yeah.
If you ever try to bring cupcakes to your kid's school, don't even try it. You are also seeing reports now that food allergy is going down because of the early introduction. Like, what are the dynamics in food allergy, big picture wise?
I would say the guidelines, just to take a step back, the guidelines were always introduce milk at age one, egg at age two, and peanuts at age three. Obviously, the guidelines have shifted back with the LEAP study to introduce it at 6 months. We see some of that adopted. I would say it's a relatively cumbersome protocol on how much you're supposed to give each week for the child to desensitize. I will say there was a study in Australia. Australia does a very nice job with food allergies and capturing data, and they have early introduction, and there was pretty good adherence to it. They didn't see a rate in the actual incidence then of food allergies. I think there's-
Hmm.
There's some, you know, reports, and they've been more database looks that say it's reduced some, but it's certainly gonna be, I would say what I heard coming out of AAAA I, introduce the food early, diagnose early, and I think that's the benefit of the early introduction you're alluding to, and then the ability to hit that window of opportunity to treat early, desensitize, and hopefully disease modify for the long run is the goal.
What do we know about prevalence in that target market, the 1-year to 7-year-olds?
Yeah. One to seven, it's about 100,000 children per age cohort coming out of the birth cohort, so an incidence of about 100,000 a year, so 670,000 age 1 to 7. As I said, only about 20% grow out of it, so 80% of this are living with it for a lifetime. We've looked at claims data that there's majority of them are in the healthcare system. A lot of them have other atopic conditions, whether it's atopic dermatitis or other food allergies, so we see that. They have those allergy visits and have an active relationship there.
670,000 patients. You know, any idea how many of those would be addressable or good candidates? Is that people who've had a reaction or people-
Yeah.
...who get, like, a skin prick test diagnosis? How do you think about segmentation?
Yeah. So I'd say they're all gonna be good candidates for our product. I know that's not a marketer's term, but that's the simple thing is when we look at that category, the majority, 90%, are doing epinephrine and avoidance, right? They're waiting for the bad event, they're using epinephrine, and they're trying to avoid the foods. I think the ability to actually transform that to a more proactive approach in desensitizing is really where you know the field is kinda heading on this.
The other interesting dynamic of the past 12 months-18 months is the introduction of XOLAIR.
Yeah.
Talk a little bit about learnings from that launch and how you guys are differentiated?
I think there's been a lot of interest in the food allergy category since XOLAIR's launch. I think their public report is about 120,000 patients on XOLAIR. I'd start with these are two very different approaches. XOLAIR is going to tamp down IgE. It's not disease modifying, but it certainly has a role to play in food allergy. Where we see the usage of it is typically in kind of teenagers and up, when we've looked at claims data. That said, it's an important role for them to have that, but we see very limited penetration of that in the youngest children, kind of 1 to 7, mostly because it's a needle and there's a bit of uncertainty around what IgE suppression would do long term.
How about, you know, the aspect of immune modulation? We're at AAAAI as well, and I think one thing that I picked up on was allergists getting really excited about actually, like, maybe retraining their patients' immune system.
Yeah. I think that's the premise of VIASKIN, that this can re-educate the immune system over time. You know, that low. I don't know if I said that in my opening, but this is 250 micrograms on every patch, so we're exposing the child to 1/1000th of a peanut daily. That's where the whole Langerhans cells to Tregs helps to, you know, use the process to actually work on full desensitization and hopefully tolerance. I do think immunomodulation, which this could be called-
Mm.
...is really where a lot of the science is heading.
Before XOLAIR had its, you know, recent success, we had PALFORZIA, an oral immunotherapy, do very poorly commercially. You know, what to learn from that, if anything?
Yeah. A few things. You know, first, there's not a lot of allergists in this country that do OIT at scale. I think we've looked, and it's around 100 that I'd say treat 25-50 patients annually. There, there's some that offer it, but don't do it at scale. I would also say it takes up an enormous amount of capacity in the office. You need nurses, hotlines, et cetera, so another reason why you can't actually scale it to the larger population. I don't think the launch of it was poor. I think they had relatively good market access. They invested a lot of money. They had high awareness. I just think the profile didn't meet what we've seen for almost a decade now of what parents want-
Mm.
...which is something that's first and foremost safe, second is, you know, has good efficacy and can fit into daily lives. Kids can go play and there's no waiting period. OIT had a lot of those complexities around it with REMS. That said, OIT is a good option for some patients and parents that wanna go through that. I just think that this has a profile that fits the 90% that are doing avoidance and epi today in this age range.
You know, another interesting thing to think about is potential pricing ranges because, you know, PALFORZIA came out, I think it was, like, $11,000 a year-
Mm.
...ballpark.
Yeah.
XOLAIR is, you know, dependent on size and then based on IgE, so those prices are kinda all over the place. How do you think about a pricing band that makes sense when you're going to the payers and presenting the profile that you guys have now proven clinically?
Yeah. It's work we're doing, obviously, as I sit here. I think the value proposition just speaks for itself. I think allergists see the value, parents see the value, and I think payers will see the value. I think in our initial discussions, we've heard, you know, PALFORZIA maybe is an analog, but I think the value proposition is very different here, right? I mean, you're gonna be able to desensitize kids for the long term for outcomes. I think the PALFORZIA experiment wasn't particularly a good one, and I think here we'll be able to articulate that value proposition and have the support behind it.
We're obviously not gonna make a pricing decision until we see final label, get input from the quantitative research we're doing, and make sure we're pricing to get as much access as we can so we can get this product to patients.
So 4-year to 7-year-olds coming first.
Mm.
You know, what does that look like with an age range where we may need longer term therapy than that? I can't imagine a payer would be like, "Hey, you can't have coverage when you turn eight.
Yeah.
What are you guys preparing for and what do you expect?
Yeah. The conversations, I think it's consistent with XOLAIR and with PALFORZIA's label. The conversation is around age of initiation, so if you start at seven, in our age range, you'll be able to continue for the 3-5 years of therapy. A payer's not gonna stop that. You know, they see this, these are the youngest children, toddlers and children. I think if there's truly a potential for disease modification, raising thresholds, decreasing severity, I think they'll understand the value there, and we'll certainly price to the value of the product, but again, keeping an eye on access.
One question we get a lot from investors is how to think about VIASKIN competing in a world where a lot of people have multiple food allergies at one time. As XOLAIR, you kinda using a hammer to knock down everything at once.
Right.
You guys are more, I think, a delicate, intricate approach, but focused on peanut.
Yeah.
How to think about those patients that, you know, have multiple food allergies. Are they addressable?
Yeah.
Not in your target market?
I think a couple points there. First, you know, we've talked to parents in market research, parents with kids with multiple food allergies. They see peanut as the most severe one. It's ubiquitous in society. It's in the ice cream scoop. It's in, you know, salty snacks and foods, packaged. So that scares them a lot, right? Unlike walnut or some of the others which aren't as ubiquitous. So that's first. I'd also point to our studies. In our studies, we enrolled 56% of patients that had polyfood allergies.
Mm.
Obviously, desensitizing to peanut, and sorry for the pun, taking that off the table is what we've heard from parents, and that desensitization effect, to your earlier question, do they understand this? They do. If they know they can raise that threshold, get them to eating peanuts someday, and kinda take that out, that would be very important to them. But XOLAIR certainly has a role in some polyfood allergies. You got 8 or 9 foods, I get it.
In the 4-year to 7-year-olds, so BLA submission coming later this year. What has to be done between now and then? Is it just cleaning the data, getting it in there? Is there manufacturing? What are you guys working on to kinda get this in front of FDA?
Yeah, I mean, you know, the team is actively writing the BLA now, and you know, both the CMC section and the clinical section, and you know, it's all systems go. As we've said, we'll file before the end of the second quarter, and that's the plan, and we look forward to that, and then having the discussion with the FDA as we move forward.
Virginie, you mentioned the COMFORT toddler safety study that should be coming soon. What are we gonna learn there? What's kind of gating for moving forward in the 1-year to 3-year-olds?
We do not expect anything that we do not know. To be very clear, the FDA, when we did the EPITOPE study, which was the phase 3 trial I was referring to earlier, which was an efficacy and safety study in the 1-year to 3-year-olds, they did not pick up any significant safety signal from that study. The reason why we are doing the COMFORT safety study, which is a supplemental safety study in the 1-year to 3-year-olds, it's to comply with the ICH guidelines, which provide for 600 patients on active for six months, and that's what we are accomplishing with running the COMFORT supplemental safety study. We do not expect any new data here. It's really the last piece for us to be able to support a BLA submission for the one, two, three.
Have you guys talked through communication to the street about that result? Is it, "Hey, we completed the study, no surprises," or are we gonna get detailed safety data? Is there anything to learn?
We do not expect to learn anything new-
Okay
... from this, study.
Check the box, move forward.
Okay.
We got two BLA submissions coming soon, a launch potentially next year. Can you talk a little bit about balance sheet, capital allocation, how you think about moving forward with what you guys have, and do you need any more capital?
We're funding through the launch of the 4-year to 7-year-olds in the U.S. That's the first part, which is important. In terms of capital allocation, we are focusing and we are really building a commercial team and engine right now, making sure this commercial team has all the resources needed to have a very robust launch. That includes building commercial inventory, building a commercial team, doing targeted digital promotion. That will be for the launch. The second important capital allocation for us is also to continue to fund our R&D projects 'cause we want to continue to develop VIASKIN Peanut, but we also want to further develop our pipeline.
Talk to us a little bit about the pipeline. What are you guys working on?
The next product in line once we validated our platform with VIASKIN Peanut is cow's milk protein. That's the next candidate we would like to pursue, and we are ready to initiate a phase IIb on cow's milk protein.
What's that opportunity look like?
Yeah. I mean, when we talk to allergists and family, that's like the next one, right? I mean, they wanna know when milk is coming. They've also talked to us about, you know, like a breakfast patch, could we combine these things? But it's a big opportunity. I'm forgetting the prevalence, but it's a significant opportunity right behind peanut. But typically kids will grow out of milk as they kind of introduce it and later. It's not as pervasive or long-term as peanut.
As we're prepping for launch mode, how do you think about targeting—like, this seems to be food allergy everywhere, so number of allergists?
Yeah.
Do you tier them? How?
Yeah. 4,500 allergists. I mean, majority of them see food allergy patients. There'll be a, you know, subset of pediatricians in geographies where there's not an allergist around that we'll target as well. All of that work is ongoing now, you know, looking at claims data and kind of deciling, figuring out sales force size. We believe we can reach the majority of these targets that are treating a large proportion of the kids with about a 70-person sales force.
Mm-hmm. As far as a rollout, this could be you come in, you get a diagnosis of food allergy. An allergist can write a prescription, and then have the medication shipped to a pharmacy and picked up. So much easier than OIT's old way.
Yeah. Yeah. It actually could happen in the same visit, but you know, yes, they can get a sample, probably get samples. We'll have samples at the office. They could put the first patch on at the time of diagnosis. Maybe they'll have them come back for a visit, you know, while they kind of do their own research. There's likely to be an hour waiting period after that first application. We'll take the opportunity to educate the parents on how to apply it, you know, what to expect, all of that. A nurse practitioner can do that within the allergist office. It's a prescription shipped to their home through specialty pharmacy, and it's really an at home application after that with appropriate visits if they wanna check in on blood work or whatever.
That was another key thing I took out of the AAAA I is just the ease of the rollout is gonna be, you know, much appreciated by the allergists who are overworked and under-resourced.
Right.
Maybe to put a button, we talked a little bit about the catalyst coming up in the next 12 months, 18 months. You mentioned runway, but actually, you know, cash numbers, where are you guys today? Because we had your financing come through earlier this year, just so people are on the same page.
Yes. We haven't released our full year results for 2025, but if you look at our cash situation from our Q3 pro forma results and add in the second tranche of the financing we conducted in 2025, which unfolded at the end of December 2025 and in January 2026, and add also the proceeds from an ATM, which we opened in the last quarter of 2025, our cash is EUR 300 million. That's before burning any cash in Q4 and in Q1, but. Again, Q3 pro forma plus the ATM proceeds and the second tranche of our financing, EUR 300 million.
Gets you to launch, and then it's Kevin's job to get the money coming in.
Absolutely.
That's right.
A lot to do, guys.
Yeah.
Thank you so much for coming to join us today-
Thank you.
...telling us about all the progress.
Thank you, Jonathan.
Thank you very much.