Medigene - Successful manufacturing of first TCR therapy

Medigene’s MDG1011 trial in MM, AML and MDS is ongoing and the first MDG1011 TCR cell product has been successfully produced. Additionally, procedures to speed up patient enrolment are being rolled out, including the simplification of enrolment criteria and the addition of new trial centres. We continue to forecast that clinical data from both the Phase I part of the MDG1011 Phase I/II clinical TCR trial and the now fully enrolled Phase I/II dendritic cell (DC) vaccine trial will be available in 2019. Financials for 9M18 were above guidance, driven by a reduction in expected R&D costs. We now forecast a net loss of €16.9m in FY18 vs €18.4m previously. Additionally, Medigene announced an exclusive licence agreement with Leiden University to develop a TCR against HA-1, an antigen expressed in a range of cancers. We value Medigene at €457m.