Good day, and welcome to the DBV Conference Call. All participants will be in a listen-only mode. Should you need assistance, please Good day, and welcome to the DBV Conference Call. All participants will be in a listen-only mode. Should you need assistance, please Good day, and welcome to the DBV Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one on your telephone keypad. To withdraw your question, please press pound and then one. Please note this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead. Thank you. On Monday, March 24th, DBV Technologies issued a press release announcing that the company secured agreements with the FDA on safety exposure data required for a BLA filing for its Viaskin Peanut program in children four through seven years old, accelerating the timeline for BLA submission in this age group. Additionally, on Thursday, March 27th, DBV Technologies issued a second press release announcing a financing of up to $306.9 million, which includes gross proceeds of $125.5 million upfront upon closing, and an aggregate of $181.4 million in gross proceeds if all warrants are exercised. Both press releases are 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 ability of the company to close the financing, the expected timing of closing of the financing, and the anticipated use of proceeds from the financing, the exercise by the investors of the warrants and pre-funded warrants to be issued in connection with the financing, the company's financial condition, forecast of its cash runway, 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 of BLAs to FDA, expectations with respect to any actionable 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 Tassé, Chief Executive Officer of DBV Technologies, Dr. Pharis Mohideen, DBV's Chief Medical Officer, and Virginie Boucinha, DBV's Chief Financial Officer. I will now pass the call over to Daniel. Thank you, Katie, and thank you, everyone, for joining your call this evening. I'm thrilled to speak to you about the positive news the company issued last week. As you know, we announced the financing last Thursday that sufficiently funds the company through expected BLA submissions and commercial launch for Viaskin programs, if approved. We also announced DBV's agreement with the FDA, allowing us to accelerate the timeline for BLA submission in our four to seven-year-old program. Allow me to start by walking you through the highlights of last week's press release. Through the agreement we secured with the FDA, we are no longer required to conduct a COMFORT Children six-month supplemental safety study in the four to seven-year-old age group. The FDA has agreed the safety exposure data generated from the VITESSE phase III study and VITESSE's open label extension are sufficient to support a BLA submission for Viaskin Peanut patch in children four to seven, and we'll talk about that more a bit later on. We also reaffirmed that VITESSE top-line results are on track for the fourth quarter of this year. Given that we no longer need to conduct the COMFORT Children safety study, we anticipate submitting the BLA for our four to seven-year-old program in the first half of 2026 to accelerate the potential launch of Viaskin Peanut in the same group if approved by approximately one year. This is fantastic news, obviously not just for DBV, but most importantly for our patients and their loved ones. Finally, last Thursday, we announced that the company has secured financing of up to $306.9 million to advance DBV's Viaskin Peanut patch to BLA submission and, if approved, U.S. commercial launch. Now, before diving in, please allow me to remind you that we are conducting in parallel two independent Viaskin Peanut programs, one in toddlers, the one to three-year-old age group with the original square patch, and one in children in the four to seven-year-old age group with the modified circular patch. We intend to submit a separate BLA for each program, that is, one BLA submission anticipated in the first half of 2026 for the Viaskin Peanut program in children, and a second BLA submission anticipated in the second half of 2026 for toddlers under a formalized accelerated approval pathway, as we previously announced in December of last year. Now, let me share with you a brief overview of the financing. DBV has secured gross proceeds of $125.5 million upfront to be received upon closing the transaction, with the potential to secure another $181.4 million through the exercise of warrants. The potential to secure the $181.4 million in gross proceeds will be triggered subject to the satisfaction of the condition VITESSE meets its primary endpoint, and all warrants are exercised thereafter. If all warrants are fully exercised, DBV has the potential to raise a total of $306.9 million. I'm delighted to share that DBV will be sufficiently funded through the BLA submission and through U.S. commercialization for the Viaskin Peanut patch in four to seven, if approved. As I mentioned before, this is important to understand. We are pursuing two independent BLAs. The timing of one does not impact the timing or value of the other. We have two distinct and independent opportunities to create value. We are delighted to have clear guidance from the FDA on both Viaskin Peanut indications. The accelerated approval pathway in one to three-year-olds and a potentially expedited pathway following the development of last week in four to seven-year-olds. Accordingly, we anticipate the submission of both BLAs next year and have sufficient funds to get us there. Before we get to the details about the financing, I would like to discuss Monday's announcement concerning the written response DBV received from the FDA. Last Monday's press release announced that we have secured an agreement with the FDA on the safety exposure data that will be required for us to file a BLA in Viaskin Peanut in children four to seven. Most notably, they are no longer required to run the COMFORT Children six-month supplemental safety study to support a BLA submission in a four to seven-year-old age group. The supplemental safety study was going to recruit approximately an additional 240 participants to generate safety data prior to a BLA submission. We are thrilled that the FDA has agreed that we no longer need to run an additional safety study and that the safety data generated from our ongoing VITESSE phase III study, together with the open label extension study, will be sufficient to support a BLA in this age group. You will recall that the VITESSE phase III study, the 12-month clinical trial with a three-year open label extension in 654 participants randomized 2:1 active to placebo across 86 sites in the U.S., in Canada, Europe, the U.K., and in Australia. It is the largest phase III clinical trial for peanut allergy ever conducted in this age group. More than 400 participants were randomized to active treatments and will be included in the primary endpoint analysis. The ICH guidelines used by FDA state that a typical safety database should consist of between 300-600 subjects. At the time of BLA submission, the data generated in VITESSE and in the VITESSE OLE will yield a safety database comprised of more than 500 study participants on Viaskin Peanut patch active treatments. I'm delighted that the agency and DBV have aligned on the sufficiency of the safety exposure data required for BLA submission in four to seven-year-olds. This alignment is a combination with a great deal of ongoing communication with the agency through constructive engagement with FDA division leadership. We also wish to sincerely thank the division for their speed and common sense approach to the regulatory process. We thank them on behalf of the millions of children eagerly awaiting additional FDA-approved treatment options in peanut allergy. As I mentioned in my opening remarks, the VITESSE top-line results are on track to read out in the fourth quarter of this year. Since we no longer must conduct COMFORT Children, we have thus accelerated our plan to file a BLA in four to seven in the first half of 2026, as opposed to what we had originally guided to, which was the second half of 2026. Moreover, Viaskin Peanut also has breakthrough designation. We are thus eligible for priority review, which, as we know, will only be confirmed upon BLA acceptance. Given this news, and if approved obviously, we now expect to launch Viaskin Peanut in four to seven-year-olds approximately one year earlier than originally planned. That's a big year for patients and their families who want and deserve treatment options. Simply put, we need to move fast, and I cannot emphasize enough that data shows the treatment window is best in younger children, and we don't want children to miss that window. Both accelerated approval pathway in one to three-year-olds announced back in December, and the recognition that VITESSE is sufficiently large to support a BLA in four to seven-year-olds provides two things. One, regulatory clarity. Two, the potential of that regulatory clarity to accelerate the VP's availability to these two patient groups. Given the utmost importance of VITESSE, I invite Pharis, our Chief Medical Officer, to provide you more information and comment on the VITESSE trial and the assumptions behind its design and why we think we are positioned for success. Pharis? Thank you, Daniel. Let me remind you of some of the key design elements of the VITESSE study. We targeted a younger and more sensitive patient population relative to the four to eleven-year-old age group that we pursued in the past. This is because younger patients have more responsive immune systems, not just for Viaskin Peanut, but in general. Our post-hoc analysis of PEPITES efficacy data in peanut allergic children showed a more robust response rate among four to seven-year-old children relative to eight to eleven-year-olds. As you may recall, we presented these data in 2022 at the Canadian Society of Allergy and Clinical Immunology. We also decreased our baseline entry food challenge eliciting dose in VITESSE to 100 mg relative to the previous phase III studies, which were at 300 mg. The post-hoc analysis of PEPITES efficacy data also showed that the more sensitive patients, those with lower baseline eliciting doses, also had a more robust treatment effect. Thus, the VITESSE inclusion criteria were defined to address younger and more sensitive patients with a high unmet need. Other entry inclusion criteria for VITESSE are consistent with the other phase III studies we've conducted, including the skin prick test and serum peanut-specific IgE. As we've previously disclosed, to align with this younger, more sensitive patient population in VITESSE, we defined the statistical definition of a treatment responder as either a subject with a baseline eliciting dose less than or equal to 30 mg, who reaches an ED greater than or equal to 300 mg of peanut protein at month 12, or a subject with a baseline ED of 100 mg, who reaches an ED greater than or equal to 600 mg of peanut protein at month 12. Subjects that enter the study with a baseline eliciting dose of 30 mg will be counted as treatment responders if the month 12 eliciting dose is greater than or equal to 300 mg. This is still a two-level increase in the food challenge dosing and a clinically meaningful increase. The FDA requested that we include a 600 milligram eliciting dose response criterion consistent with other food allergy clinical trials. Thus, subjects that enter the study with a baseline eliciting dose of 100 mg must achieve a month 12 eliciting dose of at least 600 mg to be counted as a responder. Note that our previous phase III studies of Viaskin Peanut required the 30 milligram and the 100 milligram baseline eliciting dose groups to reach greater than or equal to 1,000 mg to count as a statistical responder. We expect this to result in a more robust treatment effect. To summarize, our original statistical calculations had at least 90% power with 600 randomized subjects. With 654 subjects enrolled in the study, the power is now greater than 90%, with a higher probability of meeting the primary endpoint. The final randomized subject population also turned out to have more four to five-year-olds, 57% of the enrollment, and an overall randomized study population with a lower than expected peanut-specific IgE level. Both factors, younger age and lower IgE, have been associated with more robust treatment effects with Viaskin Peanut. We are confident with the design of the VITESSE phase III study and believe we have designed a protocol that puts us in the best position to be successful. We are on schedule for top-line results in the fourth quarter of 2025. With that, I'll hand over to Virginie. Merci beaucoup, Pharis. Allow me now to provide a high-level summary of the financing we announced last week, totaling up to $306.9 million in terms of gross profit. The financing consists of an issuance of ordinary shares and pre-funded warrants, with additional warrants exercisable subject to satisfaction of specified conditions I will come back to. The financing consists of gross profit of $125.5 million to be received upon closing and an aggregate of up to $181.4 million in gross proceeds if all the warrants issued are exercised. The upon gross proceeds of $125.5 million are expected to take us into the second quarter of 2026. DBV expects that the proceeds of this funding will be used for working capital and general corporate purposes to finance the continued development of the Viaskin Peanut program, to finance the preparation and submission of a potential BLA, and to finance the readiness of the launch of Viaskin Peanut in the U.S., if approved. The warrants issued as part of the financing consist of two-year warrants, which exercise will be accelerated by the company's announcement of positive VITESSE top-line results, as described earlier by Daniel, and which, again, are anticipated in the fourth quarter of this year. If VITESSE top-line results are positive, the warrants will have to be exercised within 30 days else they will expire. To be fulsome here, warrants cannot be exercised before VITESSE top-line results. Based on positive top-line data from VITESSE, we anticipate a second installment of up to $181.4 million. dollars if 100% of the warrants are exercised. We expect that this will provide sufficient cash runway through anticipated approval and commercialization of the Viaskin Peanut patch for the four to seven-year run. Back to you, Daniel, for concluding comments. Thank you, Virginie. It goes without saying we are beyond thrilled to have secured the support of such highly regarded fundamental investors. With this newly secured capital, we look forward to the continued advancement and launch of the two Viaskin Peanut patch programs. We will, of course, continue to exercise great diligent use of our resources, ensuring a solid balance sheet in the best interest of our shareholders and future patients. This infusion of capital from leading healthcare investors, both existing and new, reflects the importance of Viaskin Peanut patch and obviously a recognition of its potential impact, significant potential impact on families. Before closing, I'll be remiss if I did not mention that in connection with the financing, we intend to propose, subject to shareholder approval at our next annual general meeting, the appointment of Dr. Christiana Bardon, Managing Partner of MPM BioImpact, who many of you know as a member of the Board of Directors of DBV. Finally, on behalf of all of us here at DBV, I want to take a moment to sincerely thank the allergy community, the allergists, patient advocacy organizations, individual patients, investigators, their families, for their ongoing, wonderful, and very well-expressed support. I'm very proud and happy to share these fantastic developments with you all today. Thank you to all of you on the phone and on the webcast for joining us today and for your continued interest in DBV. Now, I'll ask Pharis and Virginie to join me for Q&A. If you'd like to ask a question, please press star one on your phone now, and you'll be placed into the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you have a question, press star one. Our first question comes from Jon Wolleben of JMP Securities. Please go ahead. Hey, thanks for taking the question. Congrats on the progress. A couple for me. You talked a little bit about improved responses in VITESSE, so I was hoping you could talk a little bit how that translates also to what you expect for the placebo arm in that study. Wondering, do you talk about the planning of the start of COMFORT Toddlers? Lastly, the relative unmet need in the four to seven-year-old, which could come earlier versus the one to three-year-old population. I guess those three would be great to hear from. Thanks. I'll take the last one on relative sort of interest of one to three versus four to seven, and have Pharis answer the first two. Pharis? Yeah, sure. Thanks, Jon. As far as the placebo arm in VITESSE, obviously we have a lot of post-hoc data from our four to eleven-year-old study, and we can parse out the four to seven-year-olds to look at both the active as well as the placebo responses. As we described, the two changes that we made in the response criteria, and again, these are not new, they have been in place since we submitted the protocol to the FDA, being the 30 milligram going to 300 and the 100 going to 600, those really bode well for us as far as the active delta that we anticipate relative to placebo. Those changes, again, work in our favor as far as the statistical design and the conservative nature that we took in powering the study. Does that answer your question, Jon? Is there any way you can quantify what you expect? Placebo response in the prior trial versus what you expect here as well? I am sure you still think the delta is greater, but you are expecting a more robust response just in the Viaskin Peanut arm versus the placebo here? Yeah. We published the four to seven. Obviously, the PEPITES criteria was presented in 2022 in Canada. The placebo response in that trial was about 9.6%, I believe, somewhere in that ballpark. We have looked at that as well as all of our other data. We have a really good feel for where we think the placebo response is going to be based on that data. We can also look at some of the one to three-year-old data, a little bit different population, but we get the same sort of feel where we can look at a placebo response. Obviously, as we've talked about in the past, we take a very conservative approach to the treatment effect that we might see. I believe we're very well positioned as far as the projected placebo response rates. Does that help? Okay. Yeah. Can you talk about kind of startup activities for COMFORT Toddlers? Sure. We're on schedule for our second quarter to start that study, as we've said in the past. We've done as much work as we can prior to the raise, and the team is in place. They've been in place for a long time. The CRO has been selected, and everything is a go. Okay. Great. Jon, to answer your question about sort of the relative positioning of one to three and four to seven-year-olds, obviously four to seven-year-olds are one to three before that, and obviously aging to it. It's important to recognize, I think, two important sort of facts here. One, the age of diagnosis of food allergy and of peanut allergy is between the age of one and five. That's why we've always targeted one to seven because it's the sweet spot of diagnosis and just parental motivation to do something besides also being, and we've shown that clearly, younger patients tend to have more plastic immune systems. That's fact number one. Fact number two is our indication will be one to three at the age of initiation and four to seven at the age of initiation. You don't have to change path when you turn four. You don't have to stop treatment when you turn seven. In fact, we expect because that's a conversation that takes place between allergists and families of children with peanut allergies that you're going to be in treatment for four or five years. That's sort of the expectation for all forms of immunotherapy. Making the one to three and four to seven sort of division that is a result of obviously the regulatory pathway we chose to be not something that's terribly significant when it comes to what we expect to be a patient or allergist behaviors in treating those children. If that answers your question. Yes. Thank you very much. Thanks, Jon. Our next question comes from Sam Slutsky of LifeSci Capital. Please go ahead. Hey, thanks for taking the questions and congrats on all the recent progress. A couple for me. I guess obviously the Xolair launch has—hey, can you hear me? We can hear you very well. Great. Yeah. Obviously, the Xolair launch has exceeded expectations in food allergy. Could you just discuss the read-through from this on the market opportunity as a whole in food allergy and then considerations of Xolair within the competitive landscape for Viaskin Peanut? I have one more question after. That's fine. Let me take that one. Yeah, Xolair was approved about a year ago in February of 2024 for food allergies in patients one to 55. Their market in the U.S. is 17 million people. It seems Roche is very happy with the fact that they've put about 40,000 patients on treatments in 2024. If we look to use data to answer your question, actually, before I get to data, the perception by allergists and experts is that Xolair was an important addition, but likely to be used in older patients, adults or adolescents, and often for short, specific amounts of time as they're managing specific risks in their lives. The data we see now that Xolair has launched validates that. 24%, so a bit less than one-fourth of the Xolair-treated patients for food allergy have a peanut allergy, typically peanut allergy and something else, but 75% of patients do not have a peanut allergy. Of those that have a peanut allergy, among many, treated with Xolair, as we expected, close to 60% of them, I believe it is 58% of them, are adults over the age of 18. Again, as we expected, we see only 10% of these patients being between the age of one and seven. 10% of Xolair-treated patients with a peanut allergy are one to seven. That is the indication, the age range we are targeting. As we expected, most of these children, that is not a lot of them, have peanut allergy and at least three other comorbid conditions, validating what we expected. It is an important product for adult patients with food allergy. In one to seven-year-olds, it's not used very much. The major reason for that is there's not a lot of data; there is no data on long-term use of a monoclonal antibody in developing immune systems and thus making Xolair to be a really important addition. It's great that it's actually available to families who need it. It enriches the discussion in the physician's office, but it's not a treatment option that is a direct competitor to the 670,000 patients we want to treat in the U.S., between the age of one and seven. Got it. That's helpful. Just a last question. For the two age groups for Viaskin Peanut, are those BLAs linked in any way, or are they completely distinct, their submissions? Yeah. They're completely distinct. What they will share is a small part of the CMC file because it's made on the same machine, except we changed the last step of the manufacturing process as we cut it. I'm sure some safety database that is used when it comes to pooling previous studies will be also similar. The essence, the heart of the BLA are going to be distinct here, which is a bit more work for us. On the other hand, as we said, there's a natural hedging here in our regulatory strategy by having two doses here that are independent. Understood. Thank you. Thank you. Our next question comes from Sushila Hernandez. Please go ahead. Yes. Thank you for taking my question. I just have one. Does the departure of Peter Marks have any material impacts on the regulatory part of Viaskin Peanut and Xolair for children? That's an important question. Obviously, the departure of Dr. Marks, to me, is greatly regrettable. Dr. Marks runs CBER, which obviously comprises a number of review divisions. The Office of Vaccine Research and Review, where allergenic products are reviewed, is part of the Office of OVRR that's run by Dr. David Kaslow, who reports to [Dr. Marks]. Dr. Kaslow would be losing his boss at the end of the week here. The discussions we've had on the success and progress of regulatory pathway have always been entirely between us, Dr. Kaslow, and his senior leadership that are there. Dr. Kaslow is new to the agency. He joined essentially early 2023 and was not there when Dr. Marks was involved in the COVID dosing. We don't believe it has an impact given the fact that Dr. Marks was not involved directly at all in our dosing. Does that answer your question? Any other questions? Once again, to ask a question, press star one. This concludes our question and answer session. Daniel, I'll turn the conference back over to you for any additional or closing remarks. My additional remarks would be simply to thank everybody again for attending the call today. As always, we're a phone call away if you have any questions for us. Thank you again. I wish everybody a very good evening. That concludes our conference today. Thanks, everyone, for joining.