DBV Technologies Provides Operational and Business Update

Montrouge, France, June 26, 2020

DBV Technologies Provides Operational and Business Update

BLA review of Viaskin Peanut for the treatment of peanut allergy in children ages 4-11 years ongoing

Company to immediately initiate restructuring plan to extend cash runway while awaiting FDA clarity

EPITOPE Phase III trial in toddlers ages 1-3 years ongoing; treatment benefit observed in Part A analysis   

DBV Technologies (the “Company”) (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that given the Company has not yet received an update from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Viaskin Peanut, it has undergone a comprehensive business review to best position DBV for the possibility of a delay in timelines for the Viaskin Peanut BLA review. As a result, the Board of Directors has approved the immediate initiation of a global and comprehensive restructuring plan, which is expected to include a significant reduction in workforce. The Company has initiated, in compliance with French law, the mandatory consultation process with DBV’s Social and Economic Committee in France.

“We have carefully reviewed the situation and given the prevailing uncertainties, the goal of the plan that we are launching aims to preserve our core functions, extend our cash runway and maintain operating latitude to bring the first and only epicutaneous immunotherapy for the treatment of peanut allergy to patients in need, if approved,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “We continue to believe Viaskin Peanut, based on the clinical data observed to date, can change the long-term treatment paradigm of peanut allergies and lend itself well to this current healthcare environment.”

Financial and Business Updates:

As communicated on March 16, 2020, FDA notified DBV that it had questions regarding the impact of patch adhesion on efficacy. The Company promptly submitted additional data analyses that DBV believes addressed the questions put forward by the FDA and asked the FDA to provide feedback on the path forward. These data analyses, which showed that the majority of patients treated with Viaskin Peanut achieved sufficient daily application duration to experience clinical benefit, have also been published in two peer-reviewed publications^1,2. Following submission of the data analyses in April and requests for discussion, FDA did not provide further information beyond that the data was being reviewed and the target action date of August 5, 2020 remains unchanged. Given the absence of clarity from the FDA, DBV is implementing a restructuring plan that will provide the flexibility to continue the BLA review process, prepare to bring Viaskin Peanut to patients, if approved, and preserve the Company’s cash runway.