DBV Technologies S.A.

Welcome to the DBV full year 2021 financial results. My name is Adrienne, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press star then 1 on your touch-tone phone. Please note this conference is being recorded. I'll now turn the call over to Ann Pollack, and you may begin.

Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the 12 months ended December 31st, 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, the timing and results of interactions with regulatory agencies, our forecast of our cash runway, 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 DBD, Sebastian Robitaille, Chief Financial Officer, and Pharis Mohideen, Chief Medical Officer. Daniel will provide an update on Viaskin Peanut and our extended cash runway, and Sebastian will review the full year 2021 financial results. Pharis will join Sebastian and Daniel for questions at the end. I will now pass the call over to Daniel.

Thank you, Anne, and thank you all for joining us on the call this afternoon. As Anne mentioned, this evening I will provide an update on two key areas of focus for GDD. The first, the clinical and regulatory development of our modified Bioskin Peanut patch, and the second, an update on our cache management and our cache runway. Now let's start with Bioskin Peanut. During our last corporate update in December, DBD announced that we will initiate a pivotal Phase III clinical study for a modified viaSkin Peanut patch in children in the intended patient population. As we said then, we still believe now, this data from the pivotal trial will further strengthen the viaSkin Peanut label, if approved, and enhance its commercial potential, and as such, initiating this trial is our highest priority. Now, we completed the Pivotal Trial Protocol at the end of February and prepared it for submission to the FDA for their review. Now, in parallel to finalizing our proposed protocol, we also have had timely and productive exchanges with the FDA. We very much appreciate the FDA's willingness to engage with us during this critical stage of protocol alignment. So we believe that incorporating any feedback from those collaborative FDA discussions on the broad strokes of the protocol will facilitate and possibly streamline the protocol review process. We intend to submit the full protocol following that further alignment from ongoing and productive exchanges with the FDA. And now turning to our cash management. Through our continued financial diligence, we have extended our cash runway from the third quarter of this year into the first quarter of next year. So first quarter of 2023. Based on our assumptions, we believe our cash balance and significantly reduced monthly run rate provide us with sufficient time to gain alignment with the FDA, as I referred to earlier on, and gaining alignment on final pivotal protocol for Bioskin Peanut. Now as you know in biotech there's a balancing act. Extending cash runway is always a delicate balance between cutting expenses now and obviously our ability to preserve critical research and development which fuels enterprise value and growth later. I assume you want to commend DBD employees who collectively aim to do more with less and preserve their ability to thoughtfully advance our Bioskin platform in the coming year. And I'm looking forward to updating you, obviously, on our progress. At this point, let me turn the call over to Sébastien for a review of our full-year 2021 results. Seb?