4SC AG: 4SC provides Q3 highlights and financial forecast

Key highlights of Q3 2022

Key events in Q3 2022 and beyond were each made public via a press release. Details can be found in the relevant releases available at http://www.4sc.com.

Since February 2022 4SC has been largely focusing its resources on resminostat, on achieving an outcome for the ongoing pivotal RESMAIN study, where recruitment was completed and closed on 201 patients in total, and preparation for the commerciali­zation of resminostat in case of positive data. 4SC continues to anticipate topline data from the study to be available in Q2 2023 and providing the RESMAIN study results are positive, 4SC will move towards submitting an application for marketing authorization of resminostat in CTCL in Europe and the UK and to seek scientific advice in the U.S. Yakult Honsha Co., Ltd. will be responsible for submitting an application for marketing authorization for resminostat in CTCL in Japan. If approved, resminostat would be the first HDAC inhibitor approved for CTCL in Europe and the first and only drug approved for maintenance therapy in this indication.

Cash balance development in Q3 2022 and financial forecast

As of 30 September 2022, 4SC holds cash balance/funds of €14,385 thousand as compared to €15,848 thousand as of 30 June 2022.

The average monthly use of cash from operations amounted to €1,288 thousand on average in the first nine months of 2022 (9M 2021: €918 thousand).

The decrease of cash funds in the first nine months of 2022 is mainly a result of the expenditures for the ongoing clinical study RESMAIN and the closing of all open studies involving domatinostat.

Based on current financial and operating activities, the Manage­ment Board of 4SC estimates that current funds should be sufficient to finance 4SC into the fourth quarter of 2023.

Forward-looking information

Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond 4SC’s control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.