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4SC provides Q1 2017 updatePlanegg-Martinsried, )
Jason Loveridge, Ph.D., CEO of 4SC, commented:
"4SC continues to make progress advancing its core assets resminostat, 4SC-202 and 4SC-208. In January, our partner Yakult Honsha presented promising data from subgroup analysis of the Phase II study of resminostat in combination with sorafenib in liver cancer (hepatocellular carcinoma, HCC). We continue to open study centers and enroll patients in our pivotal study RESMAIN of resminostat in cutaneous T-cell lymphoma (CTCL), which opened patient enrollment in December 2016. During the quarter, we continued to add scientific evidence that underlies the rationale for combining 4SC-202 with checkpoint inhibitors in cancer that is refractory or resistant to those innovative agents. Two combination clinical studies are anticipated to start in the second half of 2017. Finally, we expect to commence formal preclinical development of 4SC-208 in order to initiate Phase I clinical evaluation.
Throughout the following months, we expect to make significant progress in developing our core assets and to further enhance the value of 4SC through signing deals with the right industry partners to pursue further development of our non-core assets."
Key highlights of Q1 2017
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).
Presented preclinical data on resminostat that supports its potential utility as maintenance therapy in advanced CTCL patients who have achieved disease control to prior therapy at two conferences in March.
Presented preclinical data on the potential anti-tumor activity of 4SC-202 as a single agent and in combination with checkpoint inhibitors at the American Association for Cancer Annual Meeting 2017 in Washington, D.C., USA.
Business outlook for 2017
Continue enrolling patients in the pivotal study RESMAIN of resminostat in CTCL.
Continue clinical development of resminostat in HCC.
Initiate two Phase II studies of 4SC-202 in combination with checkpoint inhibitors.
Initiate formal preclinical development of 4SC-208 in order to start Phase I clinical testing.
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.
Cash balance development in Q1 2017 and financial forecast
4SC's cash balance/funds amounted to EUR7,453 thousand as of 31 March 2017, compared with EUR11,333 thousand as of 31 December 2016. The decrease relates to an average monthly outflow of cash from operations of EUR1,293 thousand compared to an average monthly outflow of EUR827 thousand in 2016. The increase in Q1 2017 was driven by postponed expenses from 2016 for the RESMAIN clinical study of resminostat in CTCL. Monthly use of cash from operations was within the range forecasted for 2017 as a whole of between EUR600 thousand and EUR1,400 thousand on average per month. The Management Board of 4SC confirms that funds should be sufficient for a further twelve months of operations.
4SC will not hold a telephone conference along with today's Q1 2017 Interim Communication. According to 4SC's policy, the Company will only hold conference calls when there is significant or material newsflow.
Information set forth in this press release contains forward-looking statements, which involve a number of 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.
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