On 29 March 2017 4SC AG (4SC, FSE Prime Standard: VSC) today published the financial results of the 4SC Group for the financial year ended 31 December 2016 that presents all material reporting period developments and provides an outlook for 2017 (Press release, 4SC, MAR 29, 2017, View Source [SID1234518598]). The full report is available at 4SC’s website.

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Jason Loveridge, Ph.D., CEO of 4SC, commented:

"Since I joined the company in September 2016, we have focused our resources on our lead clinical assets, resminostat and 4SC-202. We expanded our senior leadership team and are now well set-up to further advance our products in clinical development and toward market approval.

We look forward to 2017 as a year in which we can make significant progress at 4SC. We will continue patient enrollment in our pivotal study RESMAIN of resminostat in cutaneous T-cell lymphoma (CTCL) and are actively discussing the next steps for resminostat in liver cancer (hepatocellular carcinoma, HCC) following the interesting subgroup data generated in 2016. We also plan to initiate two Phase II studies of 4SC-202 in combination with checkpoint inhibitors and to initiate formal preclinical development of 4SC-208.

Throughout 2017, we expect to make significant progress and further enhance the value of 4SC through out-licensing deals of further non-core assets."



Key highlights of 2016 and 2017 YTD

Announced positive data from subgroup analysis of the Phase II study of resminostat in combination with sorafenib as first-line therapy in 170 Asian patients with advanced-stage HCC conducted by Yakult Honsha Co., Ltd., which showed a substantial increase in overall survival in patients with above the median platelet levels at study entry (50% of study population).
Received investigational new drug approval (IND) from the U.S. Food and Drug Administration (FDA) to conduct a clinical study of resminostat in combination with sorafenib in HCC.
Initiated patient enrollment in the pivotal study RESMAIN of resminostat as maintenance therapy in patients with advanced-stage CTCL conducted in 11 European countries at more than 50 study centers.
Announced strong preclinical data on 4SC-202’s potential in both monotherapy as well as in combination with checkpoint inhibitors.
Appointed Jason Loveridge, Ph.D., as Chief Executive Officer. Promoted Frank Hermann, M.D., to Chief Development Officer and Roland Baumgartner, Ph.D., to Chief Scientific Officer.
Established an international Scientific Expert Panel (iSEP) to provide 4SC with strategic counsel on research and clinical product development.
Sold operations of 4SC Discovery to BioNTech Small Molecules GmbH.
Sold the immunology portfolio to Immunic AG in exchange for a one-time upfront payment, milestone payments and royalties on sales.
Licensed 4SC-205 to Guangzhou LingSheng Pharma Tech Co., Ltd (Link Health) for development and marketing of 4SC-205 in China, Hong Kong, Taiwan and Macao in exchange for upfront and milestone payments totaling up to €76 million.



Business outlook for 2017

Continue enrolling patients in the pivotal study RESMAIN of resminostat in CTCL.
Define the optimal route forward for resminostat in HCC.
Initiate two Phase II studies of 4SC-202 in combination with checkpoint inhibitors.
Initiate formal preclinical development of 4SC-208.
Generate further out-licensing deals for non-core assets and continue evaluating potential partnering opportunities with pharmaceutical and biotech companies to progress the clinical development of 4SC’s core pipeline assets.



Development of cash balance in full year 2016 and financial forecast

4SC’s cash balance/funds amounted to €11,333 thousand as of 31 December 2016, compared with €22,794 thousand as of 31 December 2015. The decrease relates to an average monthly outflow of cash from operations of €827 thousand as well as to the repayment of a shareholder loan amounting to €1,500 thousand. 4SC currently estimates that the liquid funds earmarked for its financing will be sufficient for another twelve months.