DBV Technologies S.A.

Welcome to the DBV Technologies third quarter 2022 earnings conference call. My name is Darrell and I'll be your operator for today's call. At this time, all participants are on a listen only mode. Later, we will conduct a question and answer session. During the question and answer session, if you have a question, please press 01 on your touchtone phone. As a reminder, this conference is being recorded. I will 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 three months ended September 30th, 2022. The press 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 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 today's call are Daniel Tassé, Chief Executive Officer of DBV, Sebastian Robitaille, Chief Financial Officer, and Pharis Mohideen, Chief Medical Officer. I'll now pass the call over to Daniel. Daniel?

And thank you, and excuse me, thank you all for joining us on this call today. Let me start with an update on VITAS, the Phase III pivotal trial of via skin peanut with the modified patch in children age 47 with a confirmed peanut allergy. On September 21st, we announced that DBD received a partial clinical hold from the FDA specific to VITES. It does not affect any other ongoing studies with via skin peanut. In the partial clinical hold letter, the FDA specified changes to elements of the VITES protocol with the intent for the trial to support a future BLA submission. The letter indicates the FDA's careful attention to the VITAS protocol. We believe it is a constructive letter that reflects and undermines the productive nature of exchanges with the FDA. We appreciate the FDA sending this letter before any subjects are enrolled in VITAS. We would much rather address the agency's additional feedback at this stage, especially if any protocol changes yield data the FDA will find more valuable when evaluating a future BLA submission. Furthermore, our recent exchanges with the agency focus on addressing the partial clinical hold letter and have occurred in a timely manner. Our top priority is to resolve the VITAS partial clinical hold and resume initiation of VITAS. We understand what the FDA is asking and satisfied with the progress we've made in the six weeks since receiving the letter. At the time we received the partial clinical hold letter, we had started submitting the protocol to study sites for subsequent approval by their institutional review boards. When we received the letter, we rescinded any submitted protocols and paused that process. However, We are continuing internal preparations for the test and are conducting certain site assessments and startup activities to support a prompt study launch once the partial clinical hold is lifted. While as of today it is premature to assess the impact of the partial clinical hold letter On other previously announced VITAS milestones, we do know we will not begin screening subjects by year end. We will communicate additional updates publicly as appropriate, including once the partial clinical hold has been lifted. When that happens, we plan to host a conference call announcing the following that announcement with the goal of providing clarity on any changes to the DTS protocol and timeline. Let me now move on to a brief update of the financial results for the nine months ending on September 30th of 2022. As of September 30th, 2022, cash and cash equivalents were $212.7 million. Net cash used in operating activities for the nine months was $31.8 million, which is a decrease of 35% from the same period of 2021 and reflects our continued implementation of budget discipline measures. Our cash runway guidance remains unchanged from our previous guidance. We continue to maximize the efficiency of our spend and remain highly disciplined In our cash management. Now looking ahead to the remainder of 2022, we will continue to keep you updated as appropriate on the Vitesse Partial Clinical Hold. We also look forward to attending the upcoming American College of Allergy, Asthma, and Immunology Annual Scientific Meeting in Louisville, Kentucky. Historically, as you know, DBV has had a strong presence at the college. We look forward to participating again this year. I want to thank everyone on the phone and webcast for joining us today. I will now ask Pharis and Sebastian to join me for the question and answer. Operator, if you could open the line for questions, that would be great.