On August 11, 2020 4SC AG (4SC, FSE Prime Standard: VSC) reported its Half-Year Report 2020, presenting all material developments up to 30 June 2020 and the Company’s current outlook (Press release, 4SC, AUG 11, 2020, View Source [SID1234563444]). The full communication is available for download on 4SC’s website.
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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 €35.165 million as compared to €45.765 million as of 31 December 2019. The monthly use of cash from operations amounted to €1.593 million on average in the first half year of 2020 (H1 2019: €1.185 million) and was below the former range of €2.2 million and €2.6 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 €2.0 million and €2.4 million for 2020 as compared to the earlier assumptions of €2.2 million to €2.6 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.