4SC AG: 4SC provides Q2 2022 and H1 2022 update

Jason Loveridge, Ph.D., CEO of 4SC, commented: "In Q1 2022 we decided to discontinue the domatinostat program and focus solely on resminostat and achieving an outcome to the pivotal RESMAIN study. These actions have helped us to preserve cash and provide sufficient runway to enable the company to execute on its revised plan until late in 2023. Progress on RESMAIN has been very positive in H1 2022, with recruitment completed and now closed for RESMAIN. As a result, and as we now have achieved almost 95% of the events required to unblind RESMAIN, we continue to expect topline data in Q2 2023."

Key highlights in Q2 2022

* RESMAIN continues on track with top-line data expected in Q2 2023 as previously indicated

2022 Business outlook

Now that recruitment for RESMAIN is completed we await the 125th event in RESMAIN to unblind the study and report the topline data. Given we now have observed almost 95% of the events required for unblinding our focus is on preparation for a positive outcome to RESMAIN and preparation of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). The Company continues to operate to budget and has sufficient cash to execute on its current plan until late in 2023.

Development of cash balance in H1 2022 and financial forecast

As of 30 June 2022, 4SC holds cash balance/funds of €17.796 million as compared to €29.022 million as of 31 December 2021. The monthly use of cash from operations amounted to €1.375 million on average in the first half year of 2022 (H1 2021: €0.943 million) and was below the range of €1.500 million and €1.800 million forecast for 2022.

Following the recent restructuring the Management Board of 4SC estimates that current funds should be sufficient to finance 4SC into Q4 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.