4SC provides Q2 2021 and H1 2021 update

Jason Loveridge, Ph.D., CEO of 4SC, commented: "In the second quarter of 2021 we saw the RESMAIN study for resminostat progress to the point where we are increasingly confident on completing recruitment in 2021, which would be a major milestone for 4SC, and as this is one of the largest studies in cutaneous T-cell lymphoma ever conducted raises expectations for seeing a – hopefully – positive outcome in 2022. In addition, we have had a very busy quarter for our domatinostat program as we advance a number of new studies in both Merkel cell and urothelial carcinoma to the cusp of recruiting the first patient. Our cash position remains strong, and we are looking forward to meeting our overall goals for 2021 during the second half of the year".

Key highlight in Q2 2021

* Published updated data from the SENSITIZE study at ASCO 2021

2021 Business outlook

Domatinostat

* Publish key data from the DONIMI investigator sponsored neoadjuvant melanoma study at ESMO 2021
* Expand the phase IIb EMERGE investigator sponsored study to 19 microsatellite-stable gastrointestinal cancer patients
* MERKLIN 1 – first checkpoint naïve Merkel cell carcinoma patient recruited in Q3 2021
* TURANDOT – investigator sponsored neoadjuvant urothelial carcinoma study – first patient recruited Q3 2021

Resminostat

* Complete recruitment in the pivotal RESMAIN study

Development of cash balance in H1 2021 and financial forecast

At the end of the first half year of 2021, 4SC holds cash balance/funds of €36.545 million as compared to €36.203 million as of 31 December 2020. The monthly use of cash from operations amounted to €0.943 million on average in the first half year of 2021 (H1 2020: €1.593 million) and was below the range of €1.0 million to €1.5 million forecast for 2021.

The decrease in the monthly use of cash as compared to H1 2020, and the increase in cash balance/funds in the first half year of 2021 as compared to the end of 2020, were both predominantly due to the transaction with Immunic in the first quarter 2021.

The Management Board of 4SC assumes that the funds should be sufficient to finance 4SC into the second half of 2022.

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.