4SC - Domatinostat R&D ramp-up in H218
During the Q218 results call, 4SC management announced that with current funds, it plans to initiate some of its additional domatinostat trials including the pivotal Merkel-cell carcinoma (MCC) study and a Phase II skin cancer checkpoint combination study. 4SC will provide further detail in H218. The SENSITIZE study (Phase Ib/II, melanoma) is on track in Europe (data H119), while a new IND will allow expansion of the study into the US in 2019. The EMERGE study (Phase II, GI cancers) is now expected to initiate in Q318 (previously H118). The multiple domatinostat studies in H218/H119 will provide several R&D catalysts while investors wait for pivotal RESMAIN study data. Enrolment for the RESMAIN study (CTCL) continues in Europe and Japan (100/150 patients by end-2018), and top-line data are now expected in H219 (previously H119). Due to this modest delay, we now forecast resminostat launch in 2021 (previously 2020), and therefore slightly lower our valuation to €327m or €10.7/share (vs €11.4/share).4SC is a biotechnology company that researches and develops drugs primarily for the treatment of cancer diseases. The Company has special expertise and clinical products in the field of epigenetics. 4SC's compounds aim to enable new therapeutic methods that offer improved efficacy and tolerability compared to the treatments available to date, both as monotherapy and in combination with other drugs. This approach is intended to enhance treatment benefits for affected patients, coupled with improvements to their life expectancy and quality of life. Adjusted for 1- for -5 stock split, April 2015Adjusted for 1- for -5 stock split, April 2015
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