Onxeo (PA:C4X)has experienced a volatile 2017 mainly due to Livatag’s Phase III ReLive not meeting its primary endpoint. The out-licensing of Validive, fresh data from several preclinical studies with core assets – AsiDNA and belinostat combinations – were more positive recent developments. Although the share price halved after the disappointing ReLive data, the asset portfolio has been radically reshaped to focus on DNA break repair inhibition and epigenetics and Onxeo has cash reach until 2020. Our updated valuation is €218m (vs €350m) or €4.3/share.
ReLive did not meet primary endpoint
As announced in September 2017, the Phase III ReLive trial with Livatag (proprietary doxorubicin-loaded nanoparticles) in advanced hepatocellular carcinoma (HCC) did not meet its primary endpoint of improving survival as a second line therapy in HCC patients over the comparison standard of care arm. Unexpected high survival in the comparison arm was the main reason given by the company. Onxeo noted that Livatag tended to show a similar efficacy as recently approved regorafenib in a subpopulation of HCC patients with well-preserved liver function (inter-trial comparison). The unmet need is significant in HCC; therefore, while Onxeo has discontinued internal development for Livatag, it plans to explore all options for licensing. However, we do not expect rapid progress in this area.
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