On April 21, 2020 4SC AG (4SC, FSE Prime Standard: VSC) reported the Q1 Announcement 2020, presenting all material developments up to 31 March 2020 and the Company’s current outlook (Press release, 4SC, APR 21, 2020, View Source [SID1234556467]). The full communication is available for download on 4SC’s website.
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Jason Loveridge, Ph.D., CEO of 4SC, commented: "Whereas the Company had made good progress on both its development programs in Q1, including the FDA accepting our IND for the MERKLIN 2 study, most recently our team has been totally engaged with minimizing the impact of the global coronavirus pandemic on our Company and our clinical studies. Reflecting the sector more broadly, 4SC is also facing a temporary suspension of new recruitment in all of its active clinical studies and our clinical team is working overtime to ensure the safety of patients and the quality of data in our ongoing studies. 4SC is well financed and can, to a certain degree, weather the inevitable delay to study completions, however it is currently difficult to predict when study recruitment will return to normal. At this very challenging time our focus is first and foremost to ensure that patients in our active clinical studies are safe and may continue to receive medication, and to prepare as best we can for when circumstances will normalise".
Key highlight in Q1 2020 and beyond
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 Phase IIa part of EMERGE study in micro-satellite stable gastrointestinal cancer
Initiate (first patient enrolled) of the Phase IIb part of the EMERGE study
Initiate the MERKLIN 2 study in Merkel cell carcinoma patients who are refractory to checkpoint blockade
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 Q1 2020 and financial forecast
As of 31 March 2020, 4SC holds cash balance/funds of €40.350 million as compared to €45.765 million as of 31 December 2019. The monthly use of cash from operations amounted to €1.677 million on average in the first quarter of 2020 (Q1 2019: €1.263 million) and was below the range of €2.2 million and €2.6 million forecast for 2020.
The increase in the monthly use of cash as compared to Q1 2019, and the decrease in cash balance/funds in the first quarter 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 believes that the funds should be sufficient to finance 4SC into the second half of 2021.