On April 18, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the Q1 Announcement 2019, presenting all material developments up to 31 March 2019 and the Company’s current outlook (Press release, 4SC, APR 18, 2019, View Source [SID1234535203]). The full communication is available for download on 4SC’s website.
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Jason Loveridge, Ph.D., CEO of 4SC, commented: "4SC continued to deliver on its targets in the first quarter of 2019, moving our products through clinical trials and towards market approval. In particular, the SENSITIZE and EMERGE studies of domatinostat are progressing well and we expect data read-outs for both during the course of this year. Both studies are expected to provide the foundation for clinical trials in the aggressive rare skin cancer Merkel cell carcinoma (MCC). Furthermore, we have recruited more than two-thirds of patients in the pivotal RESMAIN study of resminostat in the rare cancer cutaneous T-cell lymphoma (CTCL), with positive safety outcomes so far, and expect top-line data in the first half of 2020."
Key highlights in Q1 2019 and beyond
More than two thirds of patients recruited for pivotal RESMAIN study of resminostat in advanced-stage CTCL; positive safety outcomes to date.
Started third dose cohort of Phase Ib/II study SENSITIZE of domatinostat in combination with pembrolizumab in advanced-stage melanoma.
Started investigator-initiated Phase II study EMERGE of domatinostat in combination with avelumab in microsatellite-stable gastrointestinal tumors.
Dynavax Technologies Corporation (Dynavax) presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) on the combination of orally available domatinostat with Dynavax’s intra-tumoral TLR9 agonist SD-101. Dynavax also compared domatinostat to other class‑I-selective HDAC inhibitors, with domatinostat demonstrating the most significant benefit in combination with SD‑101.
A clinical cooperation partner presented preclinical data at the AACR (Free AACR Whitepaper) that confirmed domatinostat’s mode of action in the aggressive skin cancer Merkel cell carcinoma.
As part of the agreement concluded in September 2016 to sell 4SC’s non-core immunology portfolio, 4SC now became a small shareholder of Immunic Inc. (NASDAQ: IMUX) and continues to be entitled to receive royalties.
Business outlook
Top-line data of the pivotal RESMAIN study expected in H1 2020.
Results of Yakult Honsha’s Phase II study of resminostat in biliary tract cancer to be available by mid-2020.
SENSITIZE study expected to complete in H1 2019.
Safety data of EMERGE expected in Q3 2019 and early efficacy data in Q4 2019.
Expand development for domatinostat and initiate clinical trials in MCC.
Development of cash balance in Q1 2019 and financial forecast
As of 31 March 2019, 4SC holds cash balance/funds of €21.2 million as compared to €25.0 million as of 31 December 2018. The monthly use of cash from operations amounted to €1.263 million on average in the first quarter of 2019 (Q1 2018: €1.812 million) and was below the range of €1.4 million and €1.6 million forecast for 2019.
The decrease in the monthly use of cash as compared to Q1 2018, and the decrease in cash balance/funds in the first quarter of 2019 as compared to the end of 2018, were both predominantly due to costs for the ongoing clinical studies RESMAIN and SENSITIZE.
The Management Board of 4SC believes that these funds should be sufficient to finance 4SC into Q2 2020.