June 26, 2020 / 6:38 AM / in 7 days

BRIEF-Dbv Technologies: EPITOPE Phase III trial in toddlers ongoing; treatment benefit observed in Part A analysis

June 26 (Reuters) - DBV Technologies SA:

* REG-DBV TECHNOLOGIES PROVIDES OPERATIONAL AND BUSINESS UPDATE

* EPITOPE PHASE III TRIAL IN TODDLERS AGES 1-3 YEARS ONGOING; TREATMENT BENEFIT OBSERVED IN PART A ANALYSIS

* COMPANY TO IMMEDIATELY INITIATE RESTRUCTURING PLAN TO EXTEND CASH RUNWAY WHILE AWAITING FDA CLARITY

* BLA REVIEW OF VIASKIN PEANUT FOR TREATMENT OF PEANUT ALLERGY IN CHILDREN AGES 4-11 YEARS ONGOING

* ALL ONGOING CLINICAL TRIALS WILL CONTINUE AS PLANNED; HOWEVER, ENROLLMENT TIMELINES HAVE BEEN IMPACTED BY COVID-19

* PLANS TO FOCUS ON VIASKIN PEANUT AND SCALE DOWN OTHER CLINICAL PROGRAMS AND PRE-CLINICAL SPEND.

* COMPANY ANTICIPATES PROVIDING AN UPDATE REGARDING SAMPLE SIZE AND EXPECTATIONS FOR COMPLETION OF ENROLLMENT OF PART B IN SECOND HALF OF 2020

* EXPECTS THAT ITS CURRENT BALANCE OF CASH AND CASH EQUIVALENTS OF EUR 262.4 MILLION AT END OF Q1 WILL BE SUFFICIENT TO FUND OPERATIONS SIGNIFICANTLY BEYOND PRIOR GUIDANCE OF Q1 OF 2021

* FOLLOWING FEEDBACK FROM FDA ON VIASKIN PEANUT BLA REVIEW, COMPANY WILL PROVIDE UPDATED FINANCIAL GUIDANCE Source text for Eikon: Further company coverage: (Gdansk Newsroom)

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