4SC provides Q3 business update and outlook

Key highlights of Q3 2020
-The third and final dose cohort of the first part of EMERGE was completed. Safety Review Committee evaluated the safety data from the third and final dose cohort and recommended continuation into the expansion phase of the Phase Ib/II EMERGE study.
-Merck KGaA, Darmstadt, Germany and Pfizer Inc. have agreed to supply the anti-PD-L1 antibody avelumab (BAVENCIO®) for both MERKLIN 1 and 2 studies under a supply agreement.
-4SC and Maruho decided to discontinue the collaboration for the development of 4SC’s Kv1.3 inhibitors.

Jason Loveridge, Ph.D., CEO of 4SC, said: "In a similar fashion to the earlier parts of 2020, Q3 was affected by the coronavirus pandemic, particularly with respect to recruitment in our ongoing clinical studies. In spite of these challenges the 4SC team continues to move our development plan forward and in this respect we were particularly pleased with the progress made with domatinostat, which included: completion of the dose finding/safety phase of EMERGE, where we now move forward with Phase II expansion, and with the decision of Merck/Pfizer to expand our supply agreement for avelumab to both the MERKLIN 1 and 2 studies".

Business outlook
Domatinostat
-Initiate (first patient enrolled) the Phase II 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 sufficient events required to unblind the study in 2021

Cash balance development in Q3 2020 and financial forecast
As of 30 September 2020, 4SC holds cash balance/ funds of Eur34,180 thousand as compared to Eur35,165 thousand as of 30 June 2020. The average monthly use of cash from operations amounted to Eur1,172 thousand on average in the first nine months of 2020 (9M 2019: Eur1,016 thousand).
The decrease of cash funds in the first nine months of 2020 is mainly a result of the expenditures for the ongoing clinical studies RESMAIN and SENSITIZE as well as the preparations for the start of the clinical studies of domatinostat in MCC. Based on current financial and operating activities, the Management Board of 4SC is expecting a lower average monthly cash burn from operations of between Eur1,400 thousand and Eur1,700 thousand for 2020 as compared to the earlier assumptions of Eur2,000 thousand to Eur2,400 thousand. The Management Board of 4SC also believes that current funds should be sufficient to finance the Company 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.