2020 - A Year Full Of Potentials, page-25

When discussing Sepsis don’t overlook these companies who are down the Track ...........
TiGenix also continues to advance its Phase Ib/IIa clinical SEPCELL trial to evaluate Cx611, a potential first-in-class, intravenous, allogeneic (or donor derived) stem cell therapy, for the treatment of severe sepsis secondary to community-acquired pneumonia (sCAP) in patients who require mechanical ventilation and/or vasopressors. Patients are currently being recruited across 17 sites in Belgium and Spain, with further countries expected to open during 2018. In Q1 2018, the independent Data Monitoring Committee (iDMC), after reviewing the safety and efficacy data from the first 20 randomized patients, recommended to continue the study with no changes in the protocol.

Financial highlights for 2017

Key figures for the full year 2017 (consolidated)

Revenues for 2017 amounted to EUR 0.9 million, compared to EUR 26.8 million in 2016. The decrease is mainly driven by License revenues obtained from the licensing agreement signed in July 2016 with Takeda. The decrease in Royalties and Grants and other operating income during the year is due to the withdrawal in November 2016 of the marketing authorization of ChondroCelect for commercial reasons.

Total operating charges for 2017 amounted to EUR 54.1 million, compared to EUR 29.8 million in 2016. The increase is mainly due to the increase in Research and Development expenses, driven by the launch of the Phase III clinical trial for Cx601 in the United States, the launch of the Phase Ib/IIa clinical trial for Cx611 in severe sepsis and the impairment of Coretherapix acquisition assets due to the strategic decision of the Company to focus on the eASC platform and put on hold all activities related to the cardiac stem cell (CSC) platform. General and administrative expenses increased to EUR 9.9 million from EUR 8.4 million in 2016 mainly driven by the non-recurrent expenses to explore additional funding in U.S. capital markets, to comply with the U.S. Sarbanes-Oxley Act and U.S. reporting obligations and related to the MESOBLAST licensing transaction.