DBV Technologies S.A.

Good afternoon and welcome to the DBV Technologies first half 2021 financial results and business updates conference call. My name is Reece and I am the operator for the call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open up the call for your questions. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn it over to Ann Pollack, Head of Investor Relations. Ann, please proceed.

Thank you, Reese. This afternoon, DBV Technologies issued a press release that outlines our financial results for the six months ending June 30th, 2021. This release is available in the press release 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, our anticipated future interactions with regulatory agencies, and our expectations regarding our potential patient population, allergists, and patient caregivers. 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 just claims 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 Sebastian Robitaille, Chief Financial Officer. It is now my pleasure to hand the call over to Daniel.

Thank you, Anne, and thank you all for joining us in this afternoon, late afternoon, and evening. As you know, DDD's highest priority is advancing biostein peanut in both the United States and European Union. We are committed to pursuing its approval in both regions as a treatment for children ages 4 to 11 with peanut allergy. I'd like to highlight the important progress we are making on both fronts. Let's start with the U.S. We have selected two modified via skin peanut patches or MVP patches for further development after completing CHAMP, a trial in healthy adult volunteers to assess the adhesion of five modified patches versus the current patch. All five modified patches perform better than the current patch, which we refer to as CDP, in CHAMP, and we chose the lead patches based on CHAMP results, augmented by feedback from advisory boards with allergists, as well as with patient caregivers. The difference between the two selected patches is their shape. One is circular, and the other one is rectangular with rounded corners. They are both approximately 50% larger than the current patch in total surface area, but maintain the same structure of the occlusion chamber, which is comprised of the foam ring, the backing, and the peanut protein dose of 250 micrograms. The decision to advance one or both patches to trials in children ages 4 to 11 will be determined by the feedback we received from the FDA on STAMP. STAMP, which stands for Safety, Tolerability, and Adhesion of the Modified Patches, is a six-month safety and adhesion study of MVP in children ages 4 to 11 with peanut allergy that the FDA recommended we conduct. We submitted the protocol for STAMP to the FDA in the second quarter. and we are currently awaiting feedback from the agency. As you may remember, when the FDA provided guidance on a regulatory path forward for via skin peanut in January of this year, the agency agreed that a modified via skin peanut patch would not be considered a new product entity provided the occlusion chamber remains unchanged from that of the current via skin peanut patch and that the Occlusion Chamber of MDP performs similarly to that of the current patch. The FDA's agreement is the foundation utilizing data from the clinical development program of the current Bioscan peanut patch to support the modified Bioscan peanut patch. It means we could use SafeSpray efficacy from PT, and importantly, Preclinical data like toxicity data and animal models to support APLA for a modified patch. The FDA requested we conduct an assessment comparing the uptake of allergens or peanut protein between the patches, so between CVP and MVP in peanut allergic children ages four to 11 to confirm the consistency of FKC data between the current and modified patches. We refer to this trial as EQUAL and the acronym stands for Equivalence in the Uptake of Allergen. Earlier this quarter, we initiated PREQUAL, a phase one study in healthy adult volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL. In parallel, We continue to work closely with the FDA on how to best demonstrate the protein transport comparability of the modified patch, MDT, to the reference patch, CDT. We have said that we will provide timeline guidance on the modified Biaskin BLA submission once we have alignment with the FDA on the final stamp and equal protocols. We very much look forward to providing that update as soon as possible. I'd also like to provide an update on the EMA review of the marketing authorization application for Viascan Peanut. It is progressing according to established EMA processes and ongoing conversations with the EMA. We recently received the day 180 letter of outstanding issues from the EMA which is an established part of the prescribed EMA review process. And as you know, there's a letter that is meant to include any remaining questions or objections at this stage in the process. In the letter we received, the EMA indicated many of their major objections and other objections from their day 120 list of questions have been answered. One major objection remains at this time. Now we have an ongoing and constructive dialogue with DMA and have additional opportunities obviously to address their questions. As an extension of the productive nature of our relationship with DMA, we will not unilaterally bring details of our discussion into the public domain or provide further information until there is a final review decision. We will provide a response to DMA on all outstanding issues. Based on the average length of EMA evaluation as an MAA, we estimate the EMA could issue the decision on potential marketing authorization by Escampina late in the fourth quarter of 2021 or the first quarter of 2022. And now we'll turn the call over to our CFO, Sebastien Ribitaille, to review our financial results. Seb?