DBV Technologies S.A. (DBV) Earnings Call Transcript & Summary

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.