DBV Announces Topline Financial Results for First Nine Months 2013 and Provides Safety Update on Viaskin(R) Peanut
The Independent Data and Safety Monitoring Board (DSMB)
Recommends VIPES Continuation Without Modifications
BAGNEUX, France, Oct. 15, 2013 (GLOBE NEWSWIRE) -- DBV Technologies
(Euronext:DBV) (ISIN: FR0010417345), creator of Viaskin(R), a new standard in the treatment of allergy, announced today its topline financial results for first nine months 2013 and provided a clinical update on VIPES (Viaskin Peanut's Efficacy and Safety), a randomized, Phase IIb clinical trial of Viakin Peanut in peanut allergic patients.
DBV initiated VIPES in August 2012, enrolling 221 peanut-allergic patients including children, adolescents and adults. The trial is being conducted in Europe and North America by 22 different investigators.
During the second Data and Safety Monitoring Board meeting held on September 9, 2013, the independent members reviewed the safety data of all the 221 subjects randomized and treated in the VIPES study. The safety data reviewed covered duration of treatments from 1 month up to
11 months. The DSMB concluded that the VIPES study presented no safety concerns and recommended DBV to proceed with the study as per protocol.
DBV anticipates reporting VIPES 12-month topline data during the second half of 2014. Viaskin(R) Peanut was granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
Topline Financial Results for first nine months 2013
For the first nine months 2013, total revenues reached EURO2,535,963, up from EURO1,336,019 in the first six months, mainly driven by an increase in the Research Tax Credit amounting to EURO2,271,494 over the period, compared to EURO1,263,284 three months earlier. This significant increase stems from intense R&D activity. Revenues from
Diallertest(R) stood at EURO73,840, which were stable over the period.
David Schilansky, Chief Financial Officer of DBV Technologies said: "In these first nine months, we have controlled our cash burn, limiting our total burn to EURO3 to EURO4m per quarter. With all of the clinical programmes now running full speed, we anticipate similar trends going forward."
As of September 30, 2013, DBV's cash position amounted to EURO27.6 million, compared with EURO32.3 million three months earlier.
During the third quarter, the Board of Directors granted a performance-based share and stock options bonus to DBV's Chairman & CEO and to all employees, in line with the authorisations granted by DBV's General Meeting of Shareholders held on June 4, 2013 and December 9, 2011. These allocations represent a maximum dilution of 7.6% on the basis of the share capital and of the voting rights existing as of this date, and 6.6% on the basis of the fully diluted share capital and voting rights.
About DBV Technologies
DBV Technologies is opening up a decisive new approach to the treatment of allergy - a major public health issue that is constantly increasing in prevalence. Food allergies represent a true handicap in everyday life for millions of people and thus constitute a major unmet medical need. DBV Technologies has developed a unique, proprietary, worldwide-patented technology for administering an allergen to intact skin and avoiding massive transfer to the blood. The Viaskin(R) technology combines efficacy and safety as part of a treatment that seeks to improve the patient's tolerability of peanut and thus considerably lower the risk of a systemic, allergic reaction in the event of accidental exposure to the allergen. The company's significant development program has taken this revolutionary method through to the industrial stage in Europe, initially. The product's clinically proven safety of use enables the application of effective desensitization techniques (the efficacy of which is acknowledged worldwide) in the most severe forms of the allergy. DBV Technologies is focusing on food allergies (milk and peanut) for which there are currently no effective treatments. It has developed two products: Viaskin(R) Peanut and
Viaskin(R) Milk. The clinical development program for Viaskin(R) Peanut has received Fast Track designation from the US Food and Drug Administration. The company will subsequently develop a Viaskin(R) patch for young children with house dust mite allergy - a true public health issue because this pathology is one of the main risk factors for childhood asthma. DBV Technologies shares are traded on segment C of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345).
For more information on DBV Technologies, please visit our website:
CAUTION: Viaskin(R) is not approved for sale in the USA.
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Company's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Company may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Company cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. DBV technologies' business is subject to the risk factors outlined in its registration documents filed with the French Autorite des Marches Financiers.
DBV Announces Topline Financial Results for First Nine Months 2013:
CONTACT: David Schilansky
Chief Financial Officer
Tel. : +33(0)1 55 42 78 75
Financial Communication and investor relations
Emmanuel Huynh / Valentine Brouchot
Tel. : +33(0)1 44 71 94 94
Ronald Trahan, APR
Tel. : +1 508 359 4005
Alan S. Roemer
U.S. Investor Relations
The Trout Group
Tel. : +1 646 378-2945
Posted: October 2013