4SC AG provides results for financial year 2020 and outlook for 2021

Key highlights of 2020

* 4SC AG entered into an avelumab supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. for clinical combination studies of domatinostat in Merkel cell carcinoma
* First patient enrolled in the investigator sponsored DONIMI study of domatinostat in the neoadjuvant setting in melanoma
* 33 patients enrolled in 2020
* Study expected to complete recruitment and report initial data in 2021 at key cancer conference
* First patient enrolled in the MERKLIN 2 study of domatinostat in MCC
* 168 patients recruited into the pivotal RESMAIN study of resminostat in cutaneous T cell lymphoma (CTCL)
* 4SC completed a cash capital increase from authorized capital securing €7.5 million in gross proceeds 

Jason Loveridge, Ph.D., CEO of 4SC, commented: "Given the coronavirus pandemic and all the disruption that resulted from this in 2020, 4SC still made real progress in what was undoubtably a difficult year.  Although recruitment in RESMAIN slowed significantly in the first half of the year, we did see real progress in Q4 such that we now expect to complete enrollment of the study in 2021 – 190 patients being the projected number sufficient to observe the 125 events required to unblind the study.  For domatinostat, the supply deal with Merck KGaA helps to validate its potential and enabled us to advance our clinical program in Merkel cell carcinoma patients. And finally, having seen strong recruitment into the DONIMI study in the neoadjuvant setting in melanoma in 2020, we now expect to complete recruitment of the study in the first half of 2021 as planned and see initial data presented at a major conference. Thanks to strong support from both our key existing investors as well as new investors, the company remains well financed with cash into the second quarter of 2022 and we now look forward to a brighter year and interesting clinical data from our key programs in 2021."

Business outlook for 2021

Domatinostat

* Publish updated data from the SENSITIZE study in melanoma patients refractory to checkpoint blockade
* Initiate the MERKLIN 1 study in Merkel cell carcinoma patients naive to checkpoint blockade
* Complete recruitment and report initial data from the DONIMI study of domatinostat in the neoadjuvant setting in melanoma 

Resminostat

* Complete recruitment of the pivotal RESMAIN study 

Cash balance development in full year 2020 and financial forecast

4SC’s cash balance/funds were at €36,203 thousand on 31 December 2020. The average monthly operating cash burn in 2020 was €1,334 thousand, which was slightly below the range of between €1,400 thousand and €1,700 thousand forecasted in the previous Q3 announcement as a result of later payments of agreed service milestones for ongoing clinical studies.

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 quarter of 2022. Moreover, the management expects that 4SC will be able to raise additional funds through further capital measurements and to generate income with business partners. With the expected proceeds from these measures the cash reach is projected to be extended by another twelve months. The Management Board of 4SC AG is careful to point out that this assessment is based on current forecasts and that the success of the measures is subject to uncertainties, so that actual results may turn out to differ materially from these assumptions.

For 2021, 4SC is expecting an increase of average monthly use of cash from operations to between €2,200 thousand and €2,700 thousand. 4SC estimates the net loss to rise significantly compared to 2020 as its ongoing clinical studies progress, in particular the MERKLIN 2 study, which started enrolling patients in Q4 2020. Moreover, the expected start of patient recruitment into MERKLIN 1 in the first half of 2021 will additionally contribute to 4SC’s total develop­ment expenses. 

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.