10/31/2023

speaker
Conference Operator
Operator

Welcome to the DBV Third Quarter Financial Results and Business and Regulatory Update Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Start key followed by 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press Star, then 1 on your telephone keypad. To withdraw your question, please press Star, then 2. Please note this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

speaker
Katie Matthews
Investor Relations

Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the nine months ended September 30th, 2023. This press release is 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 our clinical and regulatory development plans, the design of our anticipated clinical trials, 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 course. 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, and Dr. Pharis Mohideen, DBV's Chief Medical Officer. I will now pass the call over to Daniel. Daniel?

speaker
Daniel Tassé
Chief Executive Officer

Katie, thank you, and thank you all for joining us on this call today. The purpose of today's call is to first provide a business update on our two via skin peanut programs, including the receipt of DBV's requested feedback from the FDA regarding remaining protocol design elements for our two pending supplemental safety studies, which, as you know, are named Comfort Toddlers and Comfort Children. and secondly to review with you DBV's financial results for the third quarter of 2023. Let me start by summarizing what has already been established regarding our two by skin peanut programs and developments before turning over to Pharis for an update on the requested feedback we received from the FDA and thus the next steps in our clinical and regulatory work. As you may recall, DBV is advancing in parallel to clinical programs for via skin peanut. Via skin peanut in toddlers, children aged one to three, and via skin peanut in children aged four to seven. And it's important to recognize that via skin peanut in one to three-year-olds and via skin peanut in four to seven-year-olds are separate product candidates with independent clinical and regulatory paths that we believe will ultimately support two distinct BLAs. Now let me pass it over to Pharis to share with you more details.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-