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DBV Technologies Reports Third Quarter 2021 Financial Results and Recent Regulatory Developments

Montrouge, France, October 26, 2021

DBV Technologies Reports Third Quarter 2021 Financial Results and Recent Regulatory Developments

DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today reported financial results for the third quarter of 2021. The quarterly financial statements were approved by the Board of Directors on October 26, 2021. The Company also provided regulatory updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Viaskin™ Peanut.

US Regulatory Update:

On October 14, 2021, DBV received communication from the FDA concerning the STAMP protocol submission of May 6, 2021. The FDA has requested a stepwise approach to DBV’s modified Viaskin Peanut (mVP) development program. The FDA would like to review the data from DBV’s protein uptake release study prior to providing additional comments on the STAMP protocol design.

In its communication, FDA stated that guidance is forthcoming on how best to demonstrate the protein uptake comparability of the mVP to the reference or current patch (cVP).

The STAMP trial will not be initiated until DBV receives complete feedback from the FDA.

DBV is working hard to find an efficient and timely path forward. On behalf of patients and providers urgently awaiting a therapeutic advancement in treating peanut allergy, DBV will continue to pursue our goal of bringing Viaskin Peanut to the food allergy community, said Daniel Tasse, Chief Executive Officer, DBV Technologies.

EU Regulatory Update:

The EMA review of the Viaskin Peanut Marketing Authorization Application is progressing according to established EMA processes and ongoing conversations with the EMA. DBV is preparing its responses to the Day 180 letter and evaluating how to best address the Objections, including the remaining Major Objection which questions the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study. Further exchanges with EMA are anticipated. DBV estimates the EMA could issue its decision on potential marketing authorization for Viaskin Peanut in 1Q 2022.

Financial Highlights for the Third Quarter Ended September 30, 20211

Cash and Cash Equivalents:

 Three months ended
  March 31, 20202 June 30, 2020 September 30, 2020 December 31, 2020 March 31, 2021 June 30, 2021 September 30, 2021
 (in millions)
Net (decrease) / increase in cash and cash equivalents, of which$94.2$(34.5)$(31.5)$(25.1)$(43.9)$(27.0)$(27.3)
Net cash flow used in operating activities3 (49.7) (40.2) (42.2) (33.5) (36.2) (30.3) (22.9)
Net cash flow provided by / (used in) investing and financial activities 149.7  (0.5) (1.8) (0.7) 0.3  0.8  (1.1)
Effect of exchange rate changes on cash and cash equivalents (5.8) 
Författare GlobeNewswire