Abivax Net Loss Rises as Hepatitis B Study Hits Setback

The Tip Desk · June 30, 2016 · 2 min read

The biotechnology company reported a first-half net loss of 8.274 million euros amid intensified research spending and a futility analysis for one of its lead candidates.

Abivax reported a net loss of 8.274 million euros for the first half of 2016, a 15% increase compared to the 7.170 million euro loss recorded during the same period in 2015,. The biotechnology maker, which targets the immune system to eliminate viral diseases, attributed the rising losses to the pace of expenses generated by its primary research and development programs.

Research and development costs now constitute 86% of total operating expenses, up from 83% in the first half of 2015. This intensification of activity across clinical and pre-clinical stages drove the operational loss to 10.617 million euros, a 31% increase over the 8.107 million euros lost in the first half of 2015. To support these operations, the company consolidated its research activities in Montpellier and closed its Evry site on April 30, 2016.

The company faced a significant setback with ABX 203, an immunotherapy for chronic Hepatitis B co-developed with Cuba's Centre d’Ingénierie en Génétique et Biotechnologie,. A futility analysis conducted in June 2016 indicated that it was improbable the study would achieve its primary evaluation criterion. This analysis followed a recent increase in the rate of patients excluded from the study due to viral load rebound. Abivax said the development strategy for ABX 203 is currently under review.

Despite the setback with ABX 203, the company continues to advance its flagship product, ABX 464, which targets HIV/AIDS. Currently in Phase IIa, the compound is undergoing a study called ABX464-004 to demonstrate its long-term effect on viral load. The study involves 28 patients, 21 of whom are receiving ABX 464 in addition to standard antiretroviral treatment. The company expects to make preliminary results from this study public before the end of 2016.

Other active threads include the expansion of its antiviral platform and the optimization of a lead targeting Chikungunya. The company is also seeking partners for its immune stimulant ABX 196 for use in immuno-virology and immuno-oncology.

Financial resources as of June 30, 2016, included 1.101 million euros in available cash, 25.015 million euros in term account investments, and 2.005 million euros in SICAV/OPCVM. The company stated that these resources will cover operational needs at least until the end of 2017.

Market performance declined sharply during the period. As of June 30, 2016, the share price stood at 4.59 euros, representing a 78% decrease compared to its introduction price one year prior.