4SC has reported progress with both its clinical-stage assets – resminostat, a broad spectrum HDAC inhibitor, and domatinostat, a specific Class 1 HDAC inhibitor. In January 2019, the investigator-led Phase II EMERGE study was initiated, which is testing domatinostat in gastrointestinal cancer. 4SC has developed a broad development programme for this drug, which will include several strategic options to commercialize the asset including out-licensing based on data from multiple Phase II studies and internal pivotal development for Merkel cell carcinoma. In January 2019, the resminostat RESMAIN study received a second positive DSMB safety review and the top-line results are expected in H120. 4SC remains well funded with cash of €30.8m at end-Q318, which should fund operations into 2020. Our valuation is virtually unchanged at €328m or €10.7/share.
In November 2018, the 100th patient was recruited into the pivotal RESMAIN study and top-line results are expected in H120. The RESMAIN study is evaluating resminostat in a novel indication – maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior therapy. If the study results are positive, the company plans to submit applications for approval in Europe and potentially the US, while Yakult is expected to submit an application in Japan. If subsequently approved, resminostat would be the first HDAC inhibitor approved for CTCL in Europe, and the first and only therapy approved for maintenance in either Europe, Japan or the US.
As part of the broad domatinostat development programme, a collaborator presented new preclinical data demonstrating the synergistic effect of domatinostat in combination with chemotherapy in pancreatic cancer cell lines. While pancreatic cancer is not a focus indication for 4SC, it nevertheless adds insight about the mode of action. In addition, we expect further preclinical combination studies with checkpoint inhibitors in H119 in other indications. The domatinostat Phase II EMERGE study in gastrointestinal cancer (investigator-led) has now been initiated, with the first study sites open for recruitment.
Our rNPV-based valuation is virtually unchanged at €328m or €10.7/share, due to rolling our model forward, which was offset by a lower net cash position. We keep all assumptions in our risk-adjusted NPV model unchanged. A key near-term catalyst is interim data from the SENSITIZE study (H119).