4SC AG provides results for financial year 2021 and outlook for 2022

Key highlights of 2021

The key achievements of 4SC in 2021 are summarized below:

* Signing of an agreement under which Immunic settled its remaining royalty obligation for Immunic’s lead program, IMU-838, for US-$17.25 million, payable 50% in cash and 50% in shares of Immunic Inc.’s common stock
* Recruitment target of 190 patients reached in the RESMAIN study evaluating resminostat in cutaneous T-cell lymphoma (CTCL) and subsequently 80% of events reached for unblinding the study.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "On the positive side we hit our recruitment target of 190 patients in RESMAIN in 2021, meaning we are now in a position to expect to unblind the study in the first half of 2023. With respect to domatinostat, although we did achieve a great deal in terms of clinical progress, unfortunately the data from this pool of clinical studies did not justify further investment into the domatinostat program and this was discontinued early in 2022. Going forward we are now focused on resminostat and in obtaining an outcome to the RESMAIN study. We already achieved 80% of the events required to unblind the study and are confident we will see an outcome to RESMAIN in early 2023."

Business outlook for 2022

The focus of 4SC is now on completion of the RESMAIN pivotal study of resminostat in cutaneous T cell lymphoma (CTCL). In 2022 4SC expects to achieve 95% of the requisite number of events to unblind the study. Top-line data on the primary endpoint is expected in the 1H, 2023. Should the study be positive then the Company will proceed with preparation of the Marketing Authorisation Application for the EU and will file orphan drug applications in both the EU and US. 4SC will also seek scientific advice on potential routes to approval in the US.

Cash balance development in full year 2021 and financial forecast

4SC’s cash balance/funds were at €29,022 thousand on 31 December 2021. The average monthly operating cash burn in 2021 was €1,009 thousand, which was within the range of between €1,000 thousand and €1,500 thousand forecast since the Q1 announcement. Excluding the cash contribution received from the transaction with Immunic signed in Q1 2021, the average monthly use of cash from operating activities was €1,618 thousand.

Taking into account the current financial planning and the intended operating activities, the Management Board estimates that current funds should be sufficient to finance 4SC into the second half-year of 2023.

Whilst 4SC’s funds of € 29,022 thousand at the end of 2021 are a solid cash position entering 2022, it is also clear that the funding environment for small cap biotech companies deteriorated significantly in the second half of 2021 and as such management remains cautious as to 4SC’s ability to raise additional funds through further capital measurements and to generate income with business partners.

For 2022, 4SC is expecting an increase of average monthly use of cash from operations to between €1,500 thousand and €1,800 thousand. 4SC estimates the net loss to rise compared to 2021 as its ongoing clinical studies progress or will be completed in the course of 2022.

4SC expects to continue to report annual net losses, in the short to medium term future.

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.