4SC AG: 4SC provides Q2 2020 and H1 2020 update

Jason Loveridge, Ph.D., CEO of 4SC, commented: "4SC made good progress on both its development programs in early 2020, but reflecting the broader sector, was almost totally focused on coping with the impact of the global coronavirus crisis for the majority of the first half of the year. 4SC was forced to impose a temporary suspension on new recruitment in all of its active clinical studies and our clinical team worked overtime to ensure the safety of patients, the quality of data in our ongoing studies, the rapid reopening of the majority of our key studies, and progressing studies in preparation for patient recruitment. We are hoping for a more normal second half of 2020 and remain committed to progressing our drug candidates as quickly and safely as conditions allow".

Key highlight in Q2 2020

* FDA accepted Investigational New Drug (IND) application for domatinostat in combination with avelumab (Bavencio®) in the MERKLIN 2 study.

2020 Business outlook

Domatinostat
* Publish updated data from the SENSITIZE study in melanoma patients refractory to checkpoint blockade
* Complete the Phase IIa part of EMERGE study in micro-satellite stable gastrointestinal cancers
* Initiate (first patient enrolled) the Phase IIb part of the EMERGE study
* Initiate (first patient enrolled) the MERKLIN 2 study in Merkel cell carcinoma patients who are refractory to checkpoint blockade
* Complete recruitment of the DONIMI study of domatinostat in the neoadjuvant setting in melanoma

Resminostat
* Advance recruitment in the pivotal RESMAIN study so as to see the 125 events required to unblind the study in 2021

Development of cash balance in H1 2020 and financial forecast

At the end of the first half year of 2020, 4SC holds cash balance/funds of Eur35.165 million as compared to Eur45.765 million as of 31 December 2019. The monthly use of cash from operations amounted to Eur1.593 million on average in the first half year of 2020 (H1 2019: Eur1.185 million) and was below the former range of Eur2.2 million and Eur2.6 million forecast for 2020. Based on current financial and operating activities, the Management Board is expecting a lower average monthly cash burn from operations of between Eur2.0 million and Eur2.4 million for 2020 as compared to the earlier assumptions of Eur2.2 million to Eur2.6 million.

The increase in the monthly use of cash as compared to H1 2019, and the decrease in cash balance/funds in the first half year of 2020 as compared to the end of 2019, were both predominantly due to costs for the ongoing clinical studies RESMAIN and SENSITIZE and mainly a result of the expansion of clinical programs for domatinostat, especially for the preparation of the clinical activities for the MERKLIN 2 study. The Management Board of 4SC assumes that the funds should be sufficient to finance 4SC into the second half of 2021.

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.