Good day, welcome to the DBV Technologies Regulatory Update conference call. All participants will be in 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 star then two. Please note this event is being recorded. I would now like to turn the conference over to Anne Pollack, Head of investor Relations. Please go ahead. Thank you. This evening, DBV Technologies issued a press release detailing feedback that the company received from the US Food and Drug Administration pertaining to its ongoing development program for Viaskin Peanut in toddlers one to three years old. This press release is available in the press release section of the DBV Technologies website. Before we begin, please note that today's call may contain a number of forward-looking statements, including but not limited to comments regarding our clinical and regulatory development plans, the timing and results of interactions with regulatory agencies, designs of the company's anticipated clinical trials, safety studies and human factor studies, the timing and the anticipated results of interactions with, excuse me, with regulatory agencies. Sorry for that again. The company's estimates of its cash and cash equivalents as of March 31st, 2023. Also including our forecast of our cash runway and the ability of any product candidate, 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 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 today's call are Daniel Tassé, Chief Executive Officer of DBV, and Pharis Mohideen, Chief Medical Officer. I will now pass the call over to Daniel. Daniel? Katie Matthews, thank you. Thank you all for joining us on this call for what is an important update on Viaskin Peanut. As you all know, in June of last year, we announced the top line results of EPITOPE in peanut-allergic children, ages one to three years old. As you know, it's an important population, not simply because it's a large epidemiology, it's also given the fact there's no approved product for that population. It's between the age of 1 and 4 that is a typical age of diagnosis for peanut allergies in children. It's an important population. We submitted a pre-BLA meeting request to the FDA in February to explore the potential approval of Viaskin Peanut in that toddler population. We're happy to share with you the feedback from the agency that we received recently that provides the guidance we needed to outline the clinical regulatory pathway for Viaskin Peanut in one to three year olds. I wish to come back to that in a few moments. First, I want to highlight a fundamental component of the feedback, and it is significant. As you can see on the picture here of our two patches, Viaskin Peanut for one to three year olds, the original patch, the round patch, and Viaskin Peanut for four to seven year olds, the modified patch, are two distinct product candidates on independent regulatory pathways that each address our unmet needs. These are two distinct BLAs, and I think it's important to keep that in mind. In a moment, Pharis, I'll ask Pharis to provide additional details about the FDA response we received. To summarize, the agency confirms that our phase III EPITOPE study in toddlers, ages one to three, met the pre-specified criteria for success for the primary efficacy endpoint, and thus the agency did not request an additional efficacy study. I wish to recall what were the results of EPITOPE that we unveiled last June. In that study, the original Viaskin Peanut patch demonstrated a statistically significant treatment effect with 67% of subjects in the Viaskin Peanut arm meeting the treatment responded criteria after 12 months, as compared to 33.5% of subjects that were in the placebo arm. The P value was less than.001. Importantly, the delta to placebo of the lower bound of the confidence interval was 22.4%, beating the ultimate statistical test, the pre-specified 15% required by the agency. These results were particularly compelling when you consider that there is a growing body of evidence demonstrating additional benefits come to patients for commencing treatment for peanut allergy at a younger age. The FDA is requesting that we generate additional safety data with the original Viaskin Peanut patch in this age group. We intend to conduct a safety study to bring the total safety database in one to three year olds closer to 600 patients on active treatment and as ASTRAS will expand, that is what the FDA has been guiding pretty consistently across the safety database in this population. We are very pleased that now have a well-defined path forward to a BLA submission for a toddler program, a vulnerable population with a significant unmet medical need. I now hand over the call to Pharis Mohideen, our Chief Medical Officer, to provide you all the additional details. Pharis. Thank you, Daniel. As Daniel indicated, we are very pleased that the FDA confirmed that the efficacy results from our phase III EPITOPE trial using the original Viaskin Peanut patch in toddlers ages one to three years old can support a BLA. This is critical as the FDA did not request an additional efficacy study for this BLA. Briefly recapping the EPITOPE results, which we announced in June of 2022, Viaskin Peanut demonstrated a statistically significant treatment effect with 67% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months. This compares to 33.5% of subjects in the placebo arm. A treatment responder was defined as either a subject with a baseline eliciting dose of 10 milligrams or less, who reached an eliciting dose of 300 milligrams or more of peanut protein at month 12, or a subject with a baseline eliciting dose greater than 10 milligrams, who reached an eliciting dose of 1,000 milligrams or more of peanut protein at month 12. The eliciting dose was determined using a double-blind, placebo-controlled food challenge administered at baseline and month 12. In an additional pre-specified efficacy analysis, we looked at patients who achieved an eliciting dose of 1,000 milligrams or more of peanut protein regardless of baseline eliciting dose. Using this response criterion, the original Viaskin Peanut patch also demonstrated a statistically significant treatment effect with 64.2% of subjects in the treatment arm meeting this treatment responder criterion after 12 months as compared to 29.6% of subjects in the placebo arm. The P value here was less than 0.001. Again, we view the efficacy results from EPITOPE to be very strong, and we are pleased that the agency has not requested an additional efficacy study. Turning now to the safety study that Daniel mentioned, the FDA requested a safety study in one to three year olds using the original patch. This study will not require a food challenge as part of the design. Our experience in four to 11-year-olds is that safety studies recruit faster than 12-month efficacy studies that require food challenges. We expect this safety study to follow that faster recruitment trend. Upon completion, this study will bring our safety database in one to three year olds close to 600 subjects on active treatment. The size of the safety database is consistent with the four to seven year-old peanut development program, which uses the modified patch. This new safety study will also assess patch adhesion performance with updated instructions for use that aligns with the methodology agreed with the FDA for the VITESSE phase III study. We will work with the FDA on the design of this safety study, which we believe will be very similar to the safety study we completed in four to 11-year-olds, which was called REALISE. We anticipate submission of a protocol to the FDA by the end of the second quarter this year. In addition to the safety study, we will also conduct a human factors study with the original Viaskin Peanut patch to assess the user interface in the intended age group. We have conducted a preliminary pilot human factors validation study and will use the information generated as the basis for the final human factors validation protocol. This protocol will require FDA review and alignment prior to initiation. In parallel, we continue to progress the chemistry, manufacturing, and controls or CMC sections of the BLA. The data generated from these studies will add to the significant body of evidence that we have already compiled with the original Viaskin Peanut patch. We will work diligently with the FDA on the alignment of these remaining studies so that we can potentially bring this new treatment option to peanut-allergic toddlers and their families. I'll now turn the call back to Daniel. Thank you, Pharis. In closing, received this feedback from the FDA provides us with a well-defined course of action for our toddler program. It requires studies that we believe we can complete quickly and efficiently as we work towards the completion and submission of a BLA. As we make regulatory headway, we continue to exercise financial discipline. We've ended the first quarter of 2023 with $192.3 million in cash and cash equivalents this important program while in parallel executing our VITESSE phase II clinical trial of the modified Viaskin Peanut patch in children four to seven. As you know, we screened our first patient in VITESSE this past March, anticipate top-line data from that trial in the first half of 2025. Overall, as we progress through 2023, we're advancing two distinct programs, both with potential to deliver significant benefits to peanut-allergic children while also creating sustained value for our shareholders. If approved, the original Viaskin Peanut patch will represent our first commercial product. Will provide critical validation of our continuous immunotherapy technology that we believe has potential applications not only in other allergy indications, but potentially broad utility in autoimmune and other inflammatory disorders as well. Operators, let's open the line for questions. Thank you, sir. We will now begin the question-and-answer session. To ask a question, you may press star and then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star and then two. Once again, it is star and then one to ask a question. At this time, we will pause for a moment to assemble our roster. Our first question today will come from Jon Wolleben of JMP Securities. Please go ahead. Hey, good afternoon, guys. congrats on the progress. a few questions from me. Just wondering if FDA, in their written responses, mentioned anything about adhesion rates and EPITOPE, and if you have to make any modifications to how you're measuring it, similar to how you're monitoring it in VITESSE? Let me take the first half of that, and Pharis can add information. No, the agency is asking us to measure adhesion in the safety trial the very same way we're going to be measuring it. Tools, metrics that will be used in proof of concept in four to seven-year-olds. We're pleased with that. Again, it shows consistency of the FDA's approach to this product. Although they're two distinct patches, these two distinct populations, the assessment of adhesion that is expected in one to three-year-olds is very, very similar to the one we will be performing in four to seven. Does that answer your question, Jonathan? Yes. I know you guys are gonna wait for agreement from FDA on the design, but wondering, you know, fair to assume a one-year study here? Can you remind us of how many kids were on Viaskin Peanut? Yeah. EPITOPE, and then if you'll need a placebo in the safety study? Just, you know, any of those high-level details today would be helpful. Sure, sure. You want to take it, Pharis? Yeah, sure. Hey, Jon, it's Pharis. Yeah, no, we would assume that this would follow similar study designs as REALISE, which was a six-month study, three to one randomization. We would also believe that it would be similar to what we would propose for the four to seven-year-old study. Again, the FDA had requested a safety database with patients exposed to active treatment close to 600. If you do the math on that and you subtract out the number of active subjects from EPITOPE, which was about 260 or so, throw in a three to one randomization, and that would be about the size of the study that we would expect. Does that answer your question? Consistency across- Very helpful. Roughly 400 patients, give or take a few dozen, will give us a 300 on top of the 260, taking us close to 600. Again, those numbers are not finalized and have not been blessed by the agency, but it's the ballpark. Is that helpful? One last... Yes, one last one for me, if I may. Mm-hmm. You gave us a cash update today. You previously were guiding the cash through the Vitesse readout in first half 2025. Wondering if, you know, a study like this was included in that prior guidance or how that might change, kind of your OPEX moving forward. Our OpEx will go up. That study was not part of the guidance we gave for VITESSE. Our guidance for VITESSE was we need to do to get the dosing in four to seven-year-olds efficacy and safety done. We're in a good cash position. We obviously have, two years of cash or more in our hands right now, so we can initiate the trial. That study, as well as the building up of the commercial organization, which will come obviously with the launch we expect is going to be, you know, in a, in the foreseeable future, were not part of that guidance, to be quite clear. Perfect. Thanks, and congrats again. Thank you. Again, it is star and then one to ask a question. One final reminder, please press star then one to join the question queue. At this time, we are showing no further questions. I would like to turn the conference back over to Daniel Tassé for any closing remarks. Allison, thank you. Thank you, everyone, for joining the call. It's a bit later than we usually have it with our apologies for that. We're very enthusiastic about this response from the FDA. As Pharis mentioned, we do have to run a safety trial with adhesion measurement in about 400 or so patients. These trials are. Well, 400 is smaller than VITESSE, which is 600. Stuff like that. These trials are easier to recruit, often shorter also than efficacy trials. We're gonna be working hard, obviously, getting to the agency. As our press release shows, we expect to be able to send them the protocol by the end of Q2. Given the fact this feedback from the agency was very much aligned to what's been our dialogue with them over the last little while here. 600 patients for safety, that's consistent. We made good progress on understanding adhesion performance, adhesion measurement. That they want us to measure it the same way as we do in Vitesse is something we expect and makes perfect sense. Obviously, the protocol was already quite advanced to send to the agency. Working forward, obviously providing investors and the market updates as that regulatory pathway and the specifics of those studies are being clarified. With that, wish everybody a wonderful evening, and we'll talk to you soon.