DBV Technologies S.A.

Ladies and gentlemen, thank you for standing by. This is the conference operator. The call will begin in a few moments. Again, this is the conference operator. Thank you for standing by. The call will begin in a few moments. Thank you for watching! Music Music Music Music Music Thank you. © transcript Emily Beynon Welcome to the DBV Technologies third quarter 2026 results and business update conference call. All participants will be in a 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 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 Kevin Gardner from LifeSci Advisors. Please go ahead, sir.

Thank you. This afternoon, DBV Technologies reported financial results for the third quarter of 2026. This update 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 forecast of estimated cash runway, clinical and regulatory development plans, the design and conduct of our clinical trials, are expectations with respect to the timing and results of interactions with and decisions by regulatory agencies 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 is Daniel Tassé, Chief Executive Officer of DVV. I will now pass the call over to Daniel. Daniel?

Thank you, Kevin, and thank you all for joining us today. On the call today, I'm joined by our CFO, Virginie Boucina, our CMO, Pharis Mohideen, and our Chief Operations Officer, Kevin Malobisky. Kevin is responsible for product engineering and development. He's responsible for manufacturing and for quality at DBV. The third quarter, of 2026 was a continuation of the work involved in becoming a commercial company. The highlight of the quarter was the filing of our BLA in four to seven year olds for which I will have to give a big shout out to the DBV team, to our investigators, and to the food allergy community who have all been exceptionally supportive of our efforts. I also wish to recognize the FDA's constructive engagement the last few months and look forward to working closely with them during the review process. In tandem with this important regulatory work, DBV's manufacturing and quality management teams have been working closely with Fedev Amboise, the company's contract manufacturing partner. That work which includes extensive collaboration with third-party expert consultants follows the April 2026 FD1 letter to Fareba. As we previously disclosed, the letter resulted from a September 2025 inspection of the manufacturing of a veterinary product and it included some observations focused on quality management operations and systems which makes the warning letter have site-wide implications at AMBOIS. It is understandable and reasonable that there may be questions about this and what this means for our review process and the potential approval by a skin peanut patch in 47-year-olds. And I hope to use some of our time today to discuss them. Let me introduce Kevin to provide more details of the remediation process and our pre-approval inspection preparation.